Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wembley Rubber Products (M) Sdn Bhd · Predicate Candidate Screening
61 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
332 days90th percentile
61clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982600 | PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) | Wembley Rubber Products (M) Sdn Bhd | 1999-03-12 | 228 | 0 |
| K972616 | ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN | Wembley Rubber Products (M) Sdn Bhd | 1999-01-27 | 562 | 0 |
| K972615 | CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEI | Wembley Rubber Products (M) Sdn Bhd | 1999-01-26 | 561 | 0 |
| K972621 | PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELIN | Wembley Rubber Products (M) Sdn Bhd | 1997-10-24 | 102 | 0 |
| K953213 | COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW | Wembley Rubber Products (M) Sdn Bhd | 1996-10-11 | 459 | 0 |
| K962188 | COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, | Wembley Rubber Products (M) Sdn Bhd | 1996-07-26 | 50 | 0 |
| K962189 | COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, | Wembley Rubber Products (M) Sdn Bhd | 1996-07-26 | 50 | 0 |
| K953590 | COMFIT | Wembley Rubber Products (M) Sdn Bhd | 1996-06-27 | 332 | 0 |
| K960178 | COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGE | Wembley Rubber Products (M) Sdn Bhd | 1996-05-06 | 111 | 0 |
| K960407 | COMFIT ORTHOPEDIC | Wembley Rubber Products (M) Sdn Bhd | 1996-04-26 | 88 | 0 |
| K960416 | COMFIT MICROPTIC | Wembley Rubber Products (M) Sdn Bhd | 1996-04-26 | 88 | 0 |
| K952051 | SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES) | Wembley Rubber Products (M) Sdn Bhd | 1995-12-15 | 228 | 0 |
| K952154 | SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1995-12-15 | 221 | 0 |
| K951938 | SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1995-12-15 | 234 | 0 |
| K952155 | SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1995-12-11 | 217 | 0 |
| K952052 | SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD) | Wembley Rubber Products (M) Sdn Bhd | 1995-10-30 | 182 | 0 |
| K951921 | SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES) | Wembley Rubber Products (M) Sdn Bhd | 1995-10-30 | 189 | 0 |
| K951473 | ULTIMAX | Wembley Rubber Products (M) Sdn Bhd | 1995-07-17 | 109 | 0 |
| K951662 | COMFIT/BEADED SURGEON'S GLOVE | Wembley Rubber Products (M) Sdn Bhd | 1995-05-17 | 37 | 0 |
| K943601 | COMFIT (PINK) | Wembley Rubber Products (M) Sdn Bhd | 1995-05-17 | 296 | 0 |
| K951668 | SCIPOTEX/POWDER FREE EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1995-05-17 | 37 | 0 |
| K951661 | PROFEEL | Wembley Rubber Products (M) Sdn Bhd | 1995-05-17 | 37 | 0 |
| K951667 | COMFIT/GREEN POWDERED EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1995-05-17 | 37 | 0 |
| K951455 | SCIPOTEX (PINK) | Wembley Rubber Products (M) Sdn Bhd | 1995-04-28 | 30 | 0 |
| K951456 | SCIPOTEX (BLUE) | Wembley Rubber Products (M) Sdn Bhd | 1995-04-28 | 30 | 0 |
| K951467 | ULTIMAX | Wembley Rubber Products (M) Sdn Bhd | 1995-04-28 | 29 | 0 |
| K951468 | COMFIT | Wembley Rubber Products (M) Sdn Bhd | 1995-04-28 | 29 | 0 |
| K945785 | SCIPOTEX | Wembley Rubber Products (M) Sdn Bhd | 1995-04-28 | 154 | 0 |
| K951137 | COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC) | Wembley Rubber Products (M) Sdn Bhd | 1995-04-13 | 31 | 0 |
| K951171 | SCIPOTEX | Wembley Rubber Products (M) Sdn Bhd | 1995-04-13 | 29 | 0 |
| K936266 | COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC) | Wembley Rubber Products (M) Sdn Bhd | 1995-04-13 | 469 | 0 |
| K943255 | SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED) | Wembley Rubber Products (M) Sdn Bhd | 1995-03-07 | 244 | 0 |
| K943563 | COMFIT BLUE POWDER FREE EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1995-03-07 | 228 | 0 |
| K943254 | SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED) | Wembley Rubber Products (M) Sdn Bhd | 1995-03-07 | 244 | 0 |
| K943451 | ULTIMAX POWDER FREE EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1995-02-24 | 221 | 0 |
| K943869 | ULTIMAX (GREEN POWDER FREE EXAMINATION) | Wembley Rubber Products (M) Sdn Bhd | 1995-02-21 | 197 | 0 |
| K943566 | ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED) | Wembley Rubber Products (M) Sdn Bhd | 1995-02-03 | 196 | 0 |
| K942511 | SCIPOTEX POWDER FREE EXAM GLOVES (BEADED) | Wembley Rubber Products (M) Sdn Bhd | 1995-02-03 | 253 | 0 |
| K943868 | SCIPOTEX | Wembley Rubber Products (M) Sdn Bhd | 1995-02-03 | 179 | 0 |
| K936268 | COMFIT BLUE POWDERED EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1994-12-07 | 342 | 0 |
| K944140 | COMFIT | Wembley Rubber Products (M) Sdn Bhd | 1994-12-07 | 104 | 0 |
| K942947 | COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC | Wembley Rubber Products (M) Sdn Bhd | 1994-11-30 | 160 | 0 |
| K944141 | COMFIT (STERILE) | Wembley Rubber Products (M) Sdn Bhd | 1994-10-13 | 49 | 0 |
| K942510 | SCIPOTEX POWDER FREE EXAM GLOVES (UNBEADED) | Wembley Rubber Products (M) Sdn Bhd | 1994-08-05 | 71 | 0 |
| K936267 | COMFIT PINK POWDERED EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1994-06-22 | 174 | 0 |
| K936265 | COMFIT GREEN POWDERED EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1994-06-22 | 174 | 0 |
| K941969 | ENDOPLUS | Wembley Rubber Products (M) Sdn Bhd | 1994-06-22 | 61 | 0 |
| K935866 | COMFIT POWERED EXAMINATION GLOVES(BEADED, HYPOALLERG) | Wembley Rubber Products (M) Sdn Bhd | 1994-05-18 | 166 | 0 |
| K935864 | POWDERED EXAMINATION GLOVES (HYPOALLERGENIC) | Wembley Rubber Products (M) Sdn Bhd | 1994-05-09 | 157 | 0 |
| K935464 | COMFIT | Wembley Rubber Products (M) Sdn Bhd | 1994-05-09 | 178 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda