The following data is part of a premarket notification filed by Japan World Medical Supply with the FDA for Pristine Xtra, Surgeon's Glove.
| Device ID | K883244 |
| 510k Number | K883244 |
| Device Name: | PRISTINE XTRA, SURGEON'S GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | JAPAN WORLD MEDICAL SUPPLY 4340 STEVENS CREEK BLVD. STE.110 San Jose, CA 95129 |
| Contact | Paula Terrell |
| Correspondent | Paula Terrell JAPAN WORLD MEDICAL SUPPLY 4340 STEVENS CREEK BLVD. STE.110 San Jose, CA 95129 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-02 |
| Decision Date | 1988-08-23 |