The following data is part of a premarket notification filed by N.s. Uni-gloves Sdn. Bhd. with the FDA for Uniglove Nitrile Powdered Examination Gloves.
| Device ID | K000688 |
| 510k Number | K000688 |
| Device Name: | UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES |
| Classification | Polymer 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 Leek |
| Correspondent | Robert D Vander Leek N.S. UNI-GLOVES SDN. BHD. UG HEALTHCARE (USA) INC 2420 CARSON ST. SUITE 125 Torrance, CA 90501 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-29 |
| Decision Date | 2000-04-12 |