The following data is part of a premarket notification filed by Hi-care Thai Gloves Co. Ltd. with the FDA for Palm Care Blue Nitrile Examination Gloves Powder Free.
| Device ID | K202384 |
| 510k Number | K202384 |
| Device Name: | Palm Care Blue Nitrile Examination Gloves Powder Free |
| Classification | Polymer Patient Examination Glove |
| Applicant | Hi-Care Thai Gloves Co. Ltd. 199Moo.11, T.Banpru Hat Yai, TH 90250 |
| Contact | Daniel John |
| Correspondent | Manoj Zacharias Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, IL 60504 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-20 |
| Decision Date | 2020-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843812168502 | K202384 | 000 |
| 00850053649226 | K202384 | 000 |
| 00850053649073 | K202384 | 000 |
| 00850053649219 | K202384 | 000 |
| 08859751520013 | K202384 | 000 |
| 08859751530029 | K202384 | 000 |
| 08859751530036 | K202384 | 000 |
| 08859751530043 | K202384 | 000 |
| 08859751530050 | K202384 | 000 |
| 00850048332232 | K202384 | 000 |
| 00850048332034 | K202384 | 000 |
| 00850048332027 | K202384 | 000 |
| 00850048332225 | K202384 | 000 |
| 00850048332003 | K202384 | 000 |
| 00843812168434 | K202384 | 000 |
| 00843812168458 | K202384 | 000 |
| 00843812168496 | K202384 | 000 |
| 00850053649233 | K202384 | 000 |