The following data is part of a premarket notification filed by Thai Hua Holding Co., Ltd. with the FDA for Patient Examination Gloves.
| Device ID | K102846 |
| 510k Number | K102846 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | THAI HUA HOLDING CO., LTD. 6324 MEETINGHOUSE WAY Alexandria, VA 22312 -1718 |
| Contact | Kok-kee Hon |
| Correspondent | Kok-kee Hon THAI HUA HOLDING CO., LTD. 6324 MEETINGHOUSE WAY Alexandria, VA 22312 -1718 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2011-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G196709831 | K102846 | 000 |
| G196709821 | K102846 | 000 |
| G196709811 | K102846 | 000 |
| G196709801 | K102846 | 000 |
| G196709791 | K102846 | 000 |