The following data is part of a premarket notification filed by Shen Wei Usa Inc. with the FDA for Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black And Green Colors With Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K211620 |
| 510k Number | K211620 |
| Device Name: | Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black And Green Colors With Protein Content Labeling Claim (50 Micrograms Or Less) |
| Classification | Latex Patient Examination Glove |
| Applicant | Shen Wei USA Inc. 33278 Central Ave Ste 102 Union City, CA 94587 |
| Contact | Cheryl Reep |
| Correspondent | Cheryl Reep Shen Wei USA Inc. 33278 Central Ave Ste 102 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 | 2021-05-26 |
| Decision Date | 2021-08-19 |