The following data is part of a premarket notification filed by Kao Ying Industrial Co., Ltd. with the FDA for Kao Ying.
| Device ID | K946010 |
| 510k Number | K946010 |
| Device Name: | KAO YING |
| Classification | Vinyl Patient Examination Glove |
| Applicant | KAO YING INDUSTRIAL CO., LTD. 11321 HEEADLANDS COURT Reston, VA 22091 |
| Contact | Mehul Randery |
| Correspondent | Mehul Randery KAO YING INDUSTRIAL CO., LTD. 11321 HEEADLANDS COURT Reston, VA 22091 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-09 |
| Decision Date | 1995-03-07 |