The following data is part of a premarket notification filed by Khai Hoan Joint Stock Company with the FDA for Powdered Latex Examination Gloves, Non-sterile.
| Device ID | K092681 |
| 510k Number | K092681 |
| Device Name: | POWDERED LATEX EXAMINATION GLOVES, NON-STERILE |
| Classification | Latex Patient Examination Glove |
| Applicant | KHAI HOAN JOINT STOCK COMPANY CAU SAT HAMPLET, LAI HUNG COMMUNE, BEN CAT DISTRICT Binh Duong Province, VN |
| Contact | Pham N Thanh |
| Correspondent | Pham N Thanh KHAI HOAN JOINT STOCK COMPANY CAU SAT HAMPLET, LAI HUNG COMMUNE, BEN CAT DISTRICT Binh Duong Province, VN |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-01 |
| Decision Date | 2010-02-23 |