Wear Safe (Malaysia) Sdn Bhd
KLANG Selangor, MY
WEAR SAFE (MALAYSIA) SDN BHD appears in FDA device records in KLANG Selangor, MY. FDA records list 14 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Wear Safe (Malaysia) Sdn Bhd between 1998 and 2017. The busiest year on record is 1999, with 4. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 1999 | 4 |
| 2000 | 1 |
| 2006 | 2 |
| 2009 | 3 |
| 2010 | 2 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172420 | Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim | KGO | Substantially Equivalent | |
| K101799 | POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE | LYY | Substantially Equivalent | |
| K093500 | POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE | LZC | Substantially Equivalent | |
| K092492 | POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O | LYY | Substantially Equivalent | |
| K090066 | POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE | KGO | Substantially Equivalent | |
| K090327 | POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE | LYY | Substantially Equivalent | |
| K062917 | STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50 | LYY | Substantially Equivalent | |
| K062778 | STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED | LZA | Substantially Equivalent | |
| K992675 | PATIENT NITRILE EXAMINATION GLOVES (POWDERED) | LZA | Substantially Equivalent | |
| K992681 | PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE | LYY | Substantially Equivalent | |
| K992676 | PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES | LYY | Substantially Equivalent | |
| K992678 | PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED | LZA | Substantially Equivalent | |
| K992679 | SURGEON POWDER-FREE GLOVES, LATEX, STERILE | KGO | Substantially Equivalent | |
| K973020 | PATIENT EXAMINATION POWDER-FREE GLOVES | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010602489 | 3010602489 | WEAR SAFE (MALAYSIA) SDN BHD | LOT 5068 & 5069, BATU 4 ½, KLANG Selangor 41050 MY | 2026 | |
| 3006552561 | 3006552561 | WEAR SAFE (MALAYSIA) SDN. BHD. | LOT 13726,JALAN HAJI SALLEH, BATU 5 1/4, KLANG Selangor 41050 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain