The following data is part of a premarket notification filed by Best Putra Gloves Sdn Bhd with the FDA for Powder-free, Natural Color, Latex Surgical Glove, Sterile.
| Device ID | K101102 |
| 510k Number | K101102 |
| Device Name: | POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE |
| Classification | Surgeon's Gloves |
| Applicant | BEST PUTRA GLOVES SDN BHD MOHD TAIB, KAWASAN PERINDUSTRIAN Sg Choh Rawang, Selangor, MY 48000 |
| Contact | Effendi Tenang |
| Correspondent | Effendi Tenang BEST PUTRA GLOVES SDN BHD MOHD TAIB, KAWASAN PERINDUSTRIAN Sg Choh Rawang, Selangor, MY 48000 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-20 |
| Decision Date | 2010-07-16 |