The following data is part of a premarket notification filed by Xingda Medical Products Co., Ltd. with the FDA for Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color.
| Device ID | K152720 |
| 510k Number | K152720 |
| Device Name: | Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color |
| Classification | Polymer Patient Examination Glove |
| Applicant | XINGDA MEDICAL PRODUCTS CO., LTD. SOUTH OF SHENGZHUANG VILLAGE, LUANNAN COUNTY Tangshan, CN 063502 |
| Contact | Zhang Lixia |
| Correspondent | Chu Xiaoan XINGDA MEDICAL PRODUCTS CO.,LTD. ROOM 1606 BLDG. 1. JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DIS Beijing, CN 100083 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2016-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10036000628743 | K152720 | 000 |
| 10810099841777 | K152720 | 000 |
| 10810099841760 | K152720 | 000 |
| 10810099841753 | K152720 | 000 |
| 10810099841746 | K152720 | 000 |
| 00850046808043 | K152720 | 000 |
| 00850044566112 | K152720 | 000 |
| 00850044566082 | K152720 | 000 |
| 00850044566037 | K152720 | 000 |
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| 00850047976321 | K152720 | 000 |
| 00810676034380 | K152720 | 000 |
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| 00810676034366 | K152720 | 000 |
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| 00810676033734 | K152720 | 000 |
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| 10810099841784 | K152720 | 000 |
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| 00616784251417 | K152720 | 000 |
| 00616784251318 | K152720 | 000 |
| 00616784251219 | K152720 | 000 |
| 00616784251110 | K152720 | 000 |
| 00860009046443 | K152720 | 000 |
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| 00860009233577 | K152720 | 000 |
| 00860009233560 | K152720 | 000 |
| 00860009233553 | K152720 | 000 |
| 00860009233546 | K152720 | 000 |
| 00810676033710 | K152720 | 000 |