The following data is part of a premarket notification filed by Acefit Intl., Inc. with the FDA for Latex Examination Gloves.
| Device ID | K893306 |
| 510k Number | K893306 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ACEFIT INTL., INC. 8TH/FL. 301 FU SHING N. RD., Taipei, TW |
| Contact | Mark Lin |
| Correspondent | Mark Lin ACEFIT INTL., INC. 8TH/FL. 301 FU SHING N. RD., Taipei, TW |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-18 |
| Decision Date | 1989-09-13 |