The following data is part of a premarket notification filed by Supermax Latex Products Sdn. Bhd. with the FDA for Supergloves Low Protein Powder Free Latex Examination Gloves.
| Device ID | K980071 |
| 510k Number | K980071 |
| Device Name: | SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | SUPERMAX LATEX PRODUCTS SDN. BHD. LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Buloh, Selangor, MY 47000 |
| Contact | Stanley Thai |
| Correspondent | Stanley Thai SUPERMAX LATEX PRODUCTS SDN. BHD. LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Buloh, Selangor, MY 47000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-08 |
| Decision Date | 1998-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19555002101098 | K980071 | 000 |
| 19555002101081 | K980071 | 000 |
| 19555002101074 | K980071 | 000 |
| 19555002101067 | K980071 | 000 |
| 19555002101050 | K980071 | 000 |