POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES— 510(k) K990299
Substantially EquivalentShanghai Palomar Mountain Industries, Inc.
FDA 510(k) clearance K990299 for POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES, Substantially Equivalent on 1999-03-29. Applicant: Shanghai Palomar Mountain Industries, Inc.. Device class: 1.
Clearance details
- Applicant
- Shanghai Palomar Mountain Industries, Inc.
- Product code
- Product code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Songjiang Shanghai, CN
Recent devices under product code LZA
view all- K253508 — Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile
- 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 more
- K261793 — Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
- K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green +1 more
- K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 more
More clearances from Shanghai Palomar Mountain Industries, Inc.
view all- K031142 — DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
- K031072 — DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E
- K030094 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
- K030148 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
- K023560 — ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED
Adverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.