Wembley Rubber Products (M) Sdn Bhd
Kuala Lumpur, Malaysia, MY
Wembley Rubber Products (M) Sdn Bhd appears in FDA device records in Kuala Lumpur, Malaysia, MY. FDA records list 61 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 61
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 61FDA records hold 61 510(k) clearances for Wembley Rubber Products (M) Sdn Bhd between 1990 and 1999. The busiest year on record is 1995, with 28. The most recent is 1999, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 3 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 15 |
| 1995 | 28 |
| 1996 | 7 |
| 1997 | 1 |
| 1999 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K982600 | PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) | KGO | Substantially Equivalent | |
| K972616 | ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) | LYY | Substantially Equivalent | |
| K972615 | CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) | LYY | Substantially Equivalent | |
| K972621 | PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) | KGO | Substantially Equivalent | |
| K953213 | COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED) | LYY | Substantially Equivalent | |
| K962189 | COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) | LYY | Substantially Equivalent | |
| K962188 | COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) | LYY | Substantially Equivalent | |
| K953590 | COMFIT | LYY | Substantially Equivalent | |
| K960178 | COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC) | KGO | Substantially Equivalent | |
| K960416 | COMFIT MICROPTIC | KGO | Substantially Equivalent | |
| K960407 | COMFIT ORTHOPEDIC | KGO | Substantially Equivalent | |
| K952154 | SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K952051 | SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES) | LZA | Substantially Equivalent | |
| K951938 | SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K952155 | SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K952052 | SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD) | LZA | Substantially Equivalent | |
| K951921 | SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES) | LZA | Substantially Equivalent | |
| K951473 | ULTIMAX | KGO | Substantially Equivalent | |
| K951668 | SCIPOTEX/POWDER FREE EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K951667 | COMFIT/GREEN POWDERED EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K951662 | COMFIT/BEADED SURGEON'S GLOVE | KGO | Substantially Equivalent | |
| K951661 | PROFEEL | KGO | Substantially Equivalent | |
| K943601 | COMFIT (PINK) | LYY | Substantially Equivalent | |
| K951468 | COMFIT | LYY | Substantially Equivalent | |
| K951467 | ULTIMAX | LYY | Substantially Equivalent | |
| K951456 | SCIPOTEX (BLUE) | LYY | Substantially Equivalent | |
| K951455 | SCIPOTEX (PINK) | LYY | Substantially Equivalent | |
| K945785 | SCIPOTEX | LYY | Substantially Equivalent | |
| K951171 | SCIPOTEX | LYY | Substantially Equivalent | |
| K951137 | COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC) | LYY | Substantially Equivalent | |
| K936266 | COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC) | LYY | Substantially Equivalent | |
| K943563 | COMFIT BLUE POWDER FREE EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K943255 | SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED) | KGO | Substantially Equivalent | |
| K943254 | SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED) | KGO | Substantially Equivalent | |
| K943451 | ULTIMAX POWDER FREE EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K943869 | ULTIMAX (GREEN POWDER FREE EXAMINATION) | LYY | Substantially Equivalent | |
| K943868 | SCIPOTEX | LYY | Substantially Equivalent | |
| K943566 | ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED) | KGO | Substantially Equivalent | |
| K942511 | SCIPOTEX POWDER FREE EXAM GLOVES (BEADED) | LYY | Substantially Equivalent | |
| K944140 | COMFIT | LYY | Substantially Equivalent | |
| K936268 | COMFIT BLUE POWDERED EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K942947 | COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC | LYY | Substantially Equivalent | |
| K944141 | COMFIT (STERILE) | LYY | Substantially Equivalent | |
| K942510 | SCIPOTEX POWDER FREE EXAM GLOVES (UNBEADED) | LYY | Substantially Equivalent | |
| K941969 | ENDOPLUS | BTR | Substantially Equivalent | |
| K936267 | COMFIT PINK POWDERED EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K936265 | COMFIT GREEN POWDERED EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K935866 | COMFIT POWERED EXAMINATION GLOVES(BEADED, HYPOALLERG) | LYY | Substantially Equivalent | |
| K935864 | POWDERED EXAMINATION GLOVES (HYPOALLERGENIC) | LYY | Substantially Equivalent | |
| K935464 | COMFIT | KGO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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