Cleared Traditional

K221229 - Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves

K221229 is an FDA 510(k) clearance for Powder Free Nitrile Examination Gloves, manufactured by Zibo Blue Sail Health Technology Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K221229 · Zibo Blue Sail Health Technology Co., Ltd. · General Hospital
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Jul 2022
Decision
78d
Days
Class 1
Risk

K221229 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Zibo Blue Sail Health Technology Co., Ltd. (Zibo, CN). The FDA issued a Cleared decision on July 16, 2022 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zibo Blue Sail Health Technology Co., Ltd. devices

FDA 510(k) Submission Details - K221229

510(k) Number K221229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2022
Decision Date July 16, 2022
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 1160
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K221229.
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
K221271 · Shandong Maida Medical Technology Co., Ltd. · Jul 2022
Powder-Free Nitrile Examination Glove, Non-Sterile
K221877 · Goodgloves Industries Sdn Bhd · Jul 2022
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
K220943 · Eco Medi Glove Sdn. Bhd. · Jul 2022
Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
K213574 · Grand Work Plastic Products Co., Ltd. · Jul 2022
Nitrile Medical Examination Gloves
K221108 · Anhui Fulewei Electronic Technology Co.,Ltd · Jul 2022
Disposable Medical Nitrile Examination Gloves - Non Sterile
K221454 · Guangzhou Kangling Biotechnology Co., Ltd. · Jul 2022