510(k) K170393
- Device
- Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue And Violet Blue)
- Applicant
- Zibo Chengxun Automatic Device Co., Ltd
- 510(k) number
- K170393
- Product code
- LZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-05-09
- Date received
- 2017-02-08
- Regulation
- 880.6250
- Classification name
- Polymer Patient Examination Glove
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ding Wei
- Address
- # 37 Minan Rd., High-Tech Industrial Park Zibo CN 255088 255088
FDA Registration Numbers#
- 8041003
- 3013557562
- 3010602489
- 1038758
- 3010041430
- 3014847584
- 3006979699
- 3021595900
- 3015422337
- 8041005
- 3027977504
- 3005460813
- 3013546437
- 3008261717
- 3013530281
- 3011200663
- 3015140351
- 3015335034
- 3021640893
- 3044819802
- 2939821
- 9681247
- 8041108
- 2084813
- 8041120
- 3011649314
- 3010895961
- 3010600155
- 3005060582
- 3026263452
- 3005034064
- 3017929385
- 1420054
- 3009496643
- 3002661124
- 1423537
- 3022953895
- 3036774599
- 1000266564
- 1055236
- 3015537296
- 3001124136
- 3014449454
- 3016785252
- 3010201834
- 3005632797
- 3017616393
- 3043739177
- 3014819517
- 3003823770
- 3021233711
- 3006789222
- 8041150
- 3019840054
- 3009218271
- 2648727
- 3012034017
- 3030582179
- 1054241
- 3015219124
- 9616501
- 3020521811
- 3012104670
- 3007392007
- 3010148335
- 2431014
- 3024999439
- 3038276166
- 3015142965
- 3006796582
- 1000254914
- 3004995451
- 3010194621
- 3045062172
- 3023272672
- 3010605427
- 3013514660
- 3009055041
- 3038187455
- 3016844398
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR | Kossan International Sdn Bhd | 2026-08-18 |
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | 2026-07-21 |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue | Hartalega NGC Sdn. Bhd. | 2026-07-20 |
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Sw Technologies, Inc. | 2026-06-24 |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | 2026-06-18 |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | Hartalega NGC Sdn. Bhd. | 2026-06-17 |
| K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl | S&S Glove Corporation | 2026-06-03 |
| K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | 2026-06-03 |
| K253160 | Syntex Exam Gloves | Basic Medical Technology, Inc. | 2026-01-23 |
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid | Kossan International Sdn Bhd | 2026-01-13 |
| K251141 | Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mercator Medical (Thailand), Ltd. | 2025-11-17 |
| K250861 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | Hartalega NGC Sdn. Bhd. | 2025-10-23 |
| K252075 | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC | 2025-10-17 |
| K251716 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology, Inc. | 2025-08-27 |
| K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid | Ever Global (Vietnam) Enterprise Corporation | 2025-08-21 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases