Wembley Rubber Products (M) Sdn Bhd: FDA filings under this applicant name
FDA lists 61 510(k) clearances under the applicant name “Wembley Rubber Products (M) Sdn Bhd” (first 1990, latest 1999), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 157 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 | 37 | 37 |
| KGO | Surgeon'S Gloves | 15 | 15 |
| LZA | Polymer Patient Examination Glove | 6 | 6 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| EZL | Catheter, Retention Type, Balloon | 1 | 1 |
| FMC | Patient Examination Glove | 1 | 1 |
Review panels
Most recent Wembley Rubber Products (M) Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982600 | PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) | KGO | 1999-03-12 | 228 |
| K972616 | ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) | LYY | 1999-01-27 | 562 |
| K972615 | CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) | LYY | 1999-01-26 | 561 |
| K972621 | PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) | KGO | 1997-10-24 | 102 |
| K953213 | COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED) | LYY | 1996-10-11 | 459 |
| K962189 | COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) | LYY | 1996-07-26 | 50 |
| K962188 | COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) | LYY | 1996-07-26 | 50 |
| K953590 | COMFIT | LYY | 1996-06-27 | 332 |
| K960178 | COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC) | KGO | 1996-05-06 | 111 |
| K960416 | COMFIT MICROPTIC | KGO | 1996-04-26 | 88 |
51 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wembley Rubber Products (M) 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.
- Wembley Rubber Products (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wembley Rubber Products (M) Sdn Bhd?
FDA lists 61 510(k) clearances under the applicant name “Wembley Rubber Products (M) Sdn Bhd” (first 1990, latest 1999), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wembley Rubber Products (M) Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wembley Rubber Products (M) Sdn Bhd is 157 days.
Which FDA product codes appear under Wembley Rubber Products (M) Sdn Bhd?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 37); KGO (Surgeon'S Gloves, 15); LZA (Polymer Patient Examination Glove, 6).
Next steps
- See all 61 Wembley Rubber Products (M) Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Wembley Rubber Products (M) 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.