The following data is part of a premarket notification filed by Pamitex Industries Sdn Bhd with the FDA for Health-plus, Sanitex, Reliance, Pre-powdered Latex Examination Gloves With Protein Labeling Claim (137 Mcg Or Less).
| Device ID | K991969 |
| 510k Number | K991969 |
| Device Name: | HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | PAMITEX INDUSTRIES SDN BHD BATU 2 1/2, JALAN RASAH Seremban, N.s., MY 70300 |
| Contact | Said Awang |
| Correspondent | Said Awang PAMITEX INDUSTRIES SDN BHD BATU 2 1/2, JALAN RASAH Seremban, N.s., MY 70300 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-11 |
| Decision Date | 1999-09-09 |