The following data is part of a premarket notification filed by N.s. Uni-gloves Sdn. Bhd. with the FDA for Uniglove Polymer Coated Powder-free Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K010881 |
| 510k Number | K010881 |
| Device Name: | UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | N.S. UNI-GLOVES SDN. BHD. UG HEALTHCARE (USA) INC 2420 CARSON ST. SUITE 125 Torrance, CA 90501 |
| Contact | Robert D Vander |
| Correspondent | Robert D Vander N.S. UNI-GLOVES SDN. BHD. UG HEALTHCARE (USA) INC 2420 CARSON ST. SUITE 125 Torrance, CA 90501 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-23 |
| Decision Date | 2001-05-16 |