The following data is part of a premarket notification filed by Smart Glove Corporation Sdn.bhd with the FDA for Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves.
| Device ID | K171743 |
| 510k Number | K171743 |
| Device Name: | Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Smart Glove Corporation Sdn.Bhd Lot 6487, Batu 5 3/4, Sementa, Jalan Kapar, Klang, MY 42100 |
| Contact | Khon Pu Foo |
| Correspondent | Khon Pu Foo Smart Glove Corporation Sdn.Bhd Lot 6487, Batu 5 3/4, Sementa, Jalan Kapar, Klang, MY 42100 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-12 |
| Decision Date | 2017-11-17 |