SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM— 510(k) K021058
Substantially EquivalentSyntex Healthcare Products Co., Ltd.
FDA 510(k) clearance K021058 for SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM, Substantially Equivalent on 2002-05-14. Applicant: Syntex Healthcare Products Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Syntex Healthcare Products Co., Ltd.
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xinji City, Hebei Province, CN
Recent devices under product code LYY
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- K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
- K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
- K222612 — Powder-Free Latex examination gloves
More clearances from Syntex Healthcare Products Co., Ltd.
view all- K240080 — Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K231643 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
- K103770 — SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
- K102096 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
- K052877 — POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.