The following data is part of a premarket notification filed by Qingdao Bestex Rubber & Plastic Products Co., Ltd with the FDA for Bestex Powder-free Latex Exam Gloves With Labeling Claim. (50 Micrograms Or Less).
| Device ID | K002087 |
| 510k Number | K002087 |
| Device Name: | BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD 205 NORTH BAYVIEW AVE. UNIT 4 Sunnyvale, CA 94086 |
| Contact | Zechuan Shao |
| Correspondent | Zechuan Shao QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD 205 NORTH BAYVIEW AVE. UNIT 4 Sunnyvale, CA 94086 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-10 |
| Decision Date | 2000-09-13 |