The following data is part of a premarket notification filed by Intl. Pacific Industrial Corp. (usa), Inc. with the FDA for Patient Examination Gloves (latex).
| Device ID | K892485 |
| 510k Number | K892485 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | INTL. PACIFIC INDUSTRIAL CORP. (USA), INC. 102 TUNG HOA ROAD SAN HO BUILDING 5TH FLOOR Taipei, Taiwan, R.o.c., TW |
| Contact | Jason Huang |
| Correspondent | Jason Huang INTL. PACIFIC INDUSTRIAL CORP. (USA), INC. 102 TUNG HOA ROAD SAN HO BUILDING 5TH FLOOR Taipei, Taiwan, R.o.c., TW |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-07 |
| Decision Date | 1989-09-01 |