The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Textured Powder-free Latex Examination Gloves Contains 50 Micrograms Or Less Of Total Water Extractable Protein Per Gram.
| Device ID | K011045 |
| 510k Number | K011045 |
| Device Name: | TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM |
| Classification | Latex Patient Examination Glove |
| Applicant | SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City, CA 94587 |
| Contact | Belle Chou |
| Correspondent | Belle Chou SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City, CA 94587 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-05 |
| Decision Date | 2001-09-11 |