The following data is part of a premarket notification filed by Ming Hsien Rubber Industrial Co. with the FDA for Latex Examination Gloves.
| Device ID | K891205 |
| 510k Number | K891205 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | MING HSIEN RUBBER INDUSTRIAL CO. 10605 BOOMER CIRCLE SUITE 101 Dallas, TX 75238 |
| Contact | Alex Lai |
| Correspondent | Alex Lai MING HSIEN RUBBER INDUSTRIAL CO. 10605 BOOMER CIRCLE SUITE 101 Dallas, TX 75238 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-06 |
| Decision Date | 1989-03-22 |