The following data is part of a premarket notification filed by Khai Hoan Joint Stock Company with the FDA for Powder Free Latex Examination Gloves.
| Device ID | K113685 |
| 510k Number | K113685 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | KHAI HOAN JOINT STOCK COMPANY CAU SAT HAMPLET, LAI HUNG COMMUNE, BEN CAT DISTRICT Binh Duong Province, VN Vm |
| Contact | Terence Lim |
| Correspondent | Terence Lim KHAI HOAN JOINT STOCK COMPANY CAU SAT HAMPLET, LAI HUNG COMMUNE, BEN CAT DISTRICT Binh Duong Province, VN Vm |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-15 |
| Decision Date | 2012-08-10 |