The following data is part of a premarket notification filed by Jiann Fa Rubber Factory Co., Ltd. with the FDA for Patient Examiaination Gloves (latex).
| Device ID | K892247 |
| 510k Number | K892247 |
| Device Name: | PATIENT EXAMIAINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | JIANN FA RUBBER FACTORY CO., LTD. P.O. BOX 88 FENG SHAN FENG SHAN CITY KAOHSIUNG Taiwan, R.o.c., TW |
| Contact | David Lee |
| Correspondent | David Lee JIANN FA RUBBER FACTORY CO., LTD. P.O. BOX 88 FENG SHAN FENG SHAN CITY KAOHSIUNG 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 | 1989-04-05 |
| Decision Date | 1989-06-19 |