The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Comfit Green Powder Free Examination Glove.
| Device ID | K934812 |
| 510k Number | K934812 |
| Device Name: | COMFIT GREEN POWDER FREE EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | WEMBLEY RUBBER PRODUCTS (M) SDN BHD 11TH FLOOR, MENARA APERA ULG 84, JALAN RAJA CHULAN 50200 Kuala Lumpur, Malaysia, MY |
| Contact | Ong G Chee |
| Correspondent | Ong G Chee WEMBLEY RUBBER PRODUCTS (M) SDN BHD 11TH FLOOR, MENARA APERA ULG 84, JALAN RAJA CHULAN 50200 Kuala Lumpur, Malaysia, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-07 |
| Decision Date | 1994-01-07 |