The following data is part of a premarket notification filed by Concept Rubber Products Sdn Bhd with the FDA for Alamtex Patient Examination Gloves (latex).
| Device ID | K891966 |
| 510k Number | K891966 |
| Device Name: | ALAMTEX PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | CONCEPT RUBBER PRODUCTS SDN BHD P.O. BOX W.D. 201 Penang, MY 14009 |
| Contact | Hun Lim |
| Correspondent | Hun Lim CONCEPT RUBBER PRODUCTS SDN BHD P.O. BOX W.D. 201 Penang, MY 14009 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-29 |
| Decision Date | 1989-07-14 |