The following data is part of a premarket notification filed by Universal Gloves Private Ltd. with the FDA for Latex Examination Gloves.
| Device ID | K893015 |
| 510k Number | K893015 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | UNIVERSAL GLOVES PRIVATE LTD. PLOT #15, COCHIN EXPORT PROCESSING ZONE, KAKKANAD Kerala, India, IN |
| Contact | George |
| Correspondent | George UNIVERSAL GLOVES PRIVATE LTD. PLOT #15, COCHIN EXPORT PROCESSING ZONE, KAKKANAD Kerala, India, IN |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-12 |
| Decision Date | 1989-06-19 |