FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K200633 |
0 & M Halyard, Inc |
Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove |
10/11/2020 |
K010211 |
ALLEGIANCE HEALTHCARE CORP. |
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES |
02/15/2001 |
K990677 |
AMPRI RUBBERWARE INDUSTRIES SDN BHD |
ABSOGEL CHEMOTHERAPHY GLOVES |
11/01/1999 |
K213325 |
Anhui Xinyisheng Medical Technology Co., Ltd |
Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs |
01/28/2022 |
K213076 |
Aspen Glove Sdn. Bhd. |
AspenMed+ |
12/20/2021 |
K222449 |
Better Care Plastic Technology Co., Ltd. |
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) |
08/27/2022 |
K162186 |
BRIGHTWAY HOLDINGS SDN BHD |
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12ö, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM |
03/31/2017 |
K033789 |
Cardinal Health |
LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING |
05/07/2004 |
K032444 |
Cardinal Health |
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY |
11/13/2003 |
K162858 |
Careplus (M) SDN BHD |
NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST |
07/24/2017 |
K172525 |
Central Medicare Sdn. Bhd. |
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs |
11/13/2017 |
K173942 |
Central Medicare Sdn. Bhd. |
Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs |
03/05/2018 |
K183149 |
Central Medicare Sdn. Bhd. |
Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim |
07/04/2019 |
K172642 |
Central Medicare Sdn. Bhd. |
Orange Non Sterile Powder Free Nitrile Examination Gloves |
11/28/2017 |
K213910 |
Changzhou Universal Medical Equipment Co. Ltd |
Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs |
03/10/2022 |
K180476 |
Comfort Rubber Gloves Industries Sdn. Bhd. |
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs |
05/15/2018 |
K982832 |
EMERSON & CO. S.R.L. |
PROGUARD, RR-1, RR-2 |
12/23/1998 |
K183562 |
Encompass Industries Sdn. Bhd. |
Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs |
10/23/2019 |
K193555 |
Ever Global (Vietnam) Enterprise Corp |
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate |
06/04/2020 |
K163017 |
GMP MEDICARE SDN BHD |
Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs |
03/22/2017 |
K152222 |
GMP MEDICARE SDN BHD (F25) |
NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs |
04/21/2016 |
K182382 |
GMP Medicare SDN BHD (F25) |
Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink |
08/29/2019 |
K091643 |
GX CORPORATION SDN BHD |
POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
11/02/2009 |
K220491 |
Hainan Asther Medical Equipment Co., Ltd |
Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs |
05/14/2022 |
K180646 |
Halyard Health |
Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs |
06/27/2018 |
K160709 |
Halyard Health |
HALYARD* PURPLE NITRILE û XTRA* Powder-Free Exam Gloves |
09/06/2016 |
K120336 |
HARTALEGA SDN BHD |
NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U |
06/25/2012 |
K163146 |
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD |
POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs |
02/13/2017 |
K181130 |
Hebei Titans Hongsen Medical Technology Co., LTD. |
Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs |
08/10/2018 |
K220545 |
HL Rubber Industries Sdn bhd |
Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs |
05/26/2022 |
K212639 |
Jiangsu Nanfang Medical Co., Ltd |
Disposable Medical Nitrile Examination Gloves (Non sterile) |
12/08/2021 |
K221157 |
JR Engineering & Medical Technologies (M) SDN.BHD. |
JR Medic |
08/30/2022 |
K212827 |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs |
12/06/2021 |
K101596 |
KIMBERLY-CLARK |
KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- |
07/21/2010 |
K081089 |
KIMBERLY-CLARK CORP. |
KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM |
07/14/2008 |
K062764 |
KOSSAN LATEX INDUSTRIES(M)SDN BHD |
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED |
02/27/2007 |
K102189 |
LATEXX MANUFACTURING SDN.BHD. |
POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM |
03/14/2012 |
K172864 |
Maxter Glove Manufacturing Sdn Bhd |
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs |
05/02/2018 |
K151390 |
MAXTER GLOVE MANUFACTURING SDN BHD |
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs |
05/02/2016 |
K201390 |
Medline Industires, Inc. |
Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) |
09/18/2020 |
K072197 |
METACURE SURGICAL GLOVES SDN BHD |
POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR |
03/12/2008 |
K081971 |
NITRITEX (M) SDN. BHD. |
BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES |
12/23/2008 |
K220353 |
Niujian Technology Co., Ltd |
Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs |
03/31/2022 |
K121926 |
NORTHSTAR HEALTHCARE HOLDINGS |
BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM |
09/20/2012 |
K183132 |
O & M Halyard, Inc. |
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs |
02/05/2019 |
K191230 |
O & M Halyard, Inc. |
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves |
11/08/2019 |
K102790 |
PERUSAHAAN GETAH ASAS SDN BHD |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG |
11/29/2010 |
K042805 |
PERUSAHAAN GETAH ASAS SDN BHD |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE |
12/16/2004 |
K032374 |
PERUSAHAAN GETAH ASAS SDN BHD |
POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED |
10/22/2003 |
K992162 |
SAFESKIN CORP. |
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM |
08/30/1999 |
K970135 |
SAGE PRODUCTS, INC. |
NITRILE GLOVES |
08/25/1997 |
K101822 |
SGMP CO., LTD. |
NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
11/19/2010 |
K101436 |
SHEN WEI (USA), INC. |
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) |
11/17/2010 |
K121811 |
SHEN WEI (USA), INC. |
POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES |
11/21/2012 |
K173766 |
Shen Wei USA Inc. |
PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs |
07/08/2018 |
K190159 |
Showa Best Glove, Inc. |
Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove |
05/06/2019 |
K093500 |
WEAR SAFE (MALAYSIA) SDN. BHD. |
POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE |
01/19/2010 |
K141982 |
WRP ASIA PACIFIC SDN. BHD. |
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
02/05/2015 |
K083409 |
WRP ASIA PACIFIC SDN. BHD. |
POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL |
07/29/2009 |
K083410 |
WRP ASIA PACIFIC SDN. BHD. |
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM |
07/31/2009 |
K083305 |
WRP ASIA PACIFIC SDN. BHD. |
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM |
06/18/2009 |
K083408 |
WRP ASIA PACIFIC SDN. BHD. |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
07/31/2009 |
K182383 |
YTY Industry (Manjung) Sdn Bhd |
Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue |
03/19/2019 |