FDA 510(k) Applications Submitted by WEAR SAFE (MALAYSIA) SDN. BHD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K172420 |
08/10/2017 |
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim |
Wear Safe (Malaysia) Sdn. Bhd. |
| K101799 |
06/28/2010 |
POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE |
WEAR SAFE (MALAYSIA) SDN. BHD. |
| K092492 |
08/13/2009 |
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O |
WEAR SAFE (MALAYSIA) SDN. BHD. |
| K090066 |
01/09/2009 |
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE |
WEAR SAFE (MALAYSIA) SDN. BHD. |
| K090327 |
02/09/2009 |
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE |
WEAR SAFE (MALAYSIA) SDN. BHD. |
| K093500 |
11/12/2009 |
POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE |
WEAR SAFE (MALAYSIA) SDN. BHD. |
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