NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE— 510(k) K000330
Substantially EquivalentSiam Sempermed Corp., Ltd.
FDA 510(k) clearance K000330 for NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE, Substantially Equivalent on 2000-04-05. Applicant: Siam Sempermed Corp., Ltd.. Device class: 1.
Clearance details
- Applicant
- Siam Sempermed Corp., Ltd.
- 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
- Palm Harbor, FL, US
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More clearances from Siam Sempermed Corp., Ltd.
view all- K142685 — NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE
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- K122363 — NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
- K100907 — NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
- K082957 — NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS
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.