The following data is part of a premarket notification filed by Pacific Delta Medical Supply with the FDA for Poly-flex Latex Examination Gloves.
| Device ID | K895499 |
| 510k Number | K895499 |
| Device Name: | POLY-FLEX LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PACIFIC DELTA MEDICAL SUPPLY 2386 FAIR OAKS BLVD. Sacramento, CA 95825 |
| Contact | Ron Laporte |
| Correspondent | Ron Laporte PACIFIC DELTA MEDICAL SUPPLY 2386 FAIR OAKS BLVD. Sacramento, CA 95825 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-06 |
| Decision Date | 1989-11-16 |