Wear Safe (Malaysia) Sdn. Bhd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Wear Safe (Malaysia) Sdn. Bhd.” (first 2009, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 68 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 | 1 | 50 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wear Safe (Malaysia) Sdn. Bhd. took a median 50 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 148 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 3 | 3 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Wear Safe (Malaysia) Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172420 | Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim | KGO | 2017-09-29 | 50 |
| K101799 | POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE | LYY | 2010-09-03 | 67 |
| K093500 | POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE | LZC | 2010-01-19 | 68 |
| K092492 | POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O | LYY | 2009-10-21 | 69 |
| K090066 | POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE | KGO | 2009-05-15 | 126 |
| K090327 | POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE | LYY | 2009-04-03 | 53 |
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. (8 510(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 6 510(k) clearances under the applicant name “Wear Safe (Malaysia) Sdn. Bhd.” (first 2009, latest 2017), 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 68 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, 3); KGO (Surgeon'S Gloves, 2); LZC (Medical Glove, Specialty, 1).
Next steps
- See all 6 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.