CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)— 510(k) K972615
Substantially EquivalentWembley Rubber Products (M) Sdn Bhd
FDA 510(k) clearance K972615 for CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING), Substantially Equivalent on 1999-01-26. Applicant: Wembley Rubber Products (M) Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Wembley Rubber Products (M) Sdn Bhd
- 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
- Salak Tinggi, Sepang Selangor, MY
Recent devices under product code LYY
view all- K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
- K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White)
- 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 Wembley Rubber Products (M) Sdn Bhd
view all- K982600 — PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
- K972616 — ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
- K972621 — PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
- K953213 — COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)
- K962188 — COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
Recalls naming K972615
K-number listed on FDA's recall record- Z-1080-2021 — CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004
- Z-1082-2021 — Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
- Z-1083-2021 — ChemoPlus" Chemo Prep & Admin Kit, CT4025
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972615.
Data sourced from openFDA. This site is unofficial and independent of the FDA.