Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs— 510(k) K171873

Clearance details

Applicant

Zhonghong Pulin Medical Products Co., Ltd.

Product code

Product code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2017-06-23

Decision date

2017-11-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tangshan, CN

• K253508 — Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile2026-10-29
• K262208 — Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid +2 more2026-10-01
• K261793 — Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)2026-09-09
• K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green +1 more2026-09-09
• K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 more2026-09-08

• K231029 — Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl2023-10-30
• K230662 — Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs2023-10-26
• K210460 — NitriTec Vinyl Glove Powder Free Blue2021-05-17
• K152712 — Nitrile Powder Free Patient Examination Gloves, Blue Color2016-03-09

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →