The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Powdered Latex Surgical Gloves Sterile, Sterile With Protein Content Labeling Claim.
| Device ID | K113233 |
| 510k Number | K113233 |
| Device Name: | POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM |
| Classification | Surgeon's Gloves |
| Applicant | SHEN WEI (USA), INC. 33278 CENTRAL AVE., SUITE 102 Union City, CA 94587 |
| Contact | Albert Li |
| Correspondent | Albert Li SHEN WEI (USA), INC. 33278 CENTRAL AVE., SUITE 102 Union City, CA 94587 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-02 |
| Decision Date | 2012-03-29 |
| Summary: | summary |