The following data is part of a premarket notification filed by Jiangsu Huayuan Gloves Co., Ltd. with the FDA for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K102362 |
| 510k Number | K102362 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | JIANGSU HUAYUAN GLOVES CO., LTD. NO.68 JINGYI ROAD, CHENGDONG NEW DISTRICT Dongtai, CN 224249 |
| Contact | Yu Bang Ting |
| Correspondent | Yu Bang Ting JIANGSU HUAYUAN GLOVES CO., LTD. NO.68 JINGYI ROAD, CHENGDONG NEW DISTRICT Dongtai, CN 224249 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-19 |
| Decision Date | 2010-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973082350056 | K102362 | 000 |
| 06973082350049 | K102362 | 000 |
| 06973082350032 | K102362 | 000 |
| 06973082350025 | K102362 | 000 |
| 06973082350018 | K102362 | 000 |