The following data is part of a premarket notification filed by Beta Healthcare Products Pvt.ltd. with the FDA for Pristeen (latex Surgeon’s Gloves Powder Free, Polymer Coated With Protein Content Labeling Claim Of 50 Ug/dm2 Or Less Per Glove Of Extractable Protein.
| Device ID | K172942 |
| 510k Number | K172942 |
| Device Name: | Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer Coated With Protein Content Labeling Claim Of 50 Ug/dm2 Or Less Per Glove Of Extractable Protein |
| Classification | Surgeon's Gloves |
| Applicant | Beta Healthcare Products Pvt.Ltd. Plot No 21B, Cochin Special Economic Zone Kakkanad Kochi, IN 682037 |
| Contact | Boney Moolayil |
| Correspondent | Manoj Zacharias M/s Liberty Management Group Ltd 75 Executive Dr Ste 114 Aurora, IL 60504 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2018-01-08 |
| Summary: | summary |