The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Blue Colour Powder Free Barrierpro Polymer Bp2000 Polybutadiene Copolymer Examination Gloves.
| Device ID | K061192 |
| 510k Number | K061192 |
| Device Name: | BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Elizabeth Miller,mst |
| Correspondent | Elizabeth Miller,mst ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-28 |
| Decision Date | 2006-05-23 |
| Summary: | summary |