The following data is part of a premarket notification filed by Healthy Glove Co., Ltd with the FDA for Hg Pro Xp Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs.
| Device ID | K162381 |
| 510k Number | K162381 |
| Device Name: | HG PRO XP Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | HEALTHY GLOVE CO., LTD 119 Kanchanavanich Road, Tambol Patong Hat Yai, TH 90230 |
| Contact | Teoh Choh Shee |
| Correspondent | Teoh Choh Shee HEALTHY GLOVE CO., LTD 119 Kanchanavanich Road, Tambol Patong Hat Yai, TH 90230 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-24 |
| Decision Date | 2017-01-31 |
| Summary: | summary |