Wear Safe Malaysia Sdn. Bhd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Wear Safe Malaysia Sdn. Bhd.” (first 1998, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 114 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 4 | 4 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Wear Safe Malaysia Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062917 | STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50 | LYY | 2006-11-02 | 35 |
| K062778 | STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED | LZA | 2006-10-27 | 39 |
| K992675 | PATIENT NITRILE EXAMINATION GLOVES (POWDERED) | LZA | 2000-01-20 | 163 |
| K992681 | PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE | LYY | 1999-12-16 | 128 |
| K992676 | PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES | LYY | 1999-12-16 | 128 |
| K992678 | PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED | LZA | 1999-11-17 | 99 |
| K992679 | SURGEON POWDER-FREE GLOVES, LATEX, STERILE | KGO | 1999-10-21 | 72 |
| K973020 | PATIENT EXAMINATION POWDER-FREE GLOVES | LYY | 1998-01-06 | 146 |
Recalls
openFDA lists no recalls under a recalling firm named Wear Safe Malaysia Sdn. Bhd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Wear Safe (Malaysia) Sdn. Bhd. (6 510(k)s)
- Wear Safe (Malaysia) Sdn Bhd - Facility II (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wear Safe Malaysia Sdn. Bhd.?
FDA lists 8 510(k) clearances under the applicant name “Wear Safe Malaysia Sdn. Bhd.” (first 1998, latest 2006), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wear Safe Malaysia Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wear Safe Malaysia Sdn. Bhd. is 114 days.
Which FDA product codes appear under Wear Safe Malaysia Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 4); LZA (Polymer Patient Examination Glove, 3); KGO (Surgeon'S Gloves, 1).
Next steps
- See all 8 Wear Safe Malaysia Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Wear Safe Malaysia Sdn. Bhd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.