510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Siam Sempermed Corp., Ltd.

Palm Harbor, FL, US

Siam Sempermed Corp., Ltd. appears in FDA device records in Palm Harbor, FL. FDA records list 37 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
37
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 37 510(k) clearances for Siam Sempermed Corp., Ltd. between 1989 and 2015. The busiest year on record is 2000, with 6. The most recent is 2015, with 1.

Clearances by year, as a table
510(k) clearance decisions for Siam Sempermed Corp., Ltd., by decision year
YearClearances
19891
19931
19941
19953
19963
19971
19981
20006
20026
20052
20061
20071
20083
20093
20101
20122
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K142685NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREELZASubstantially Equivalent
K121549NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUELZASubstantially Equivalent
K122363NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUELZASubstantially Equivalent
K100907NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALLLYYSubstantially Equivalent
K082957NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGSLZASubstantially Equivalent
K083755NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGSLZASubstantially Equivalent
K081911NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUELZASubstantially Equivalent
K081910NON-STERILE, POWDERED LATEX EXAMINATION GLOVELYYSubstantially Equivalent
K081907NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)LYYSubstantially Equivalent
K080520NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIMLZASubstantially Equivalent
K070639NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATINGLZASubstantially Equivalent
K060753NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL)LZASubstantially Equivalent
K052890NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN ELZASubstantially Equivalent
K051329STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)LYYSubstantially Equivalent
K024121NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIMLYYSubstantially Equivalent
K024106NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIMLYYSubstantially Equivalent
K021220NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZASubstantially Equivalent
K013267POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICSLYYSubstantially Equivalent
K014112SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER ELYYSubstantially Equivalent
K014110SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHITLYYSubstantially Equivalent
K002391NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)LZASubstantially Equivalent
K002819NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILELZASubstantially Equivalent
K002818NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILELZASubstantially Equivalent
K000330NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILELZASubstantially Equivalent
K000329NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILELZASubstantially Equivalent
K000323NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILELZASubstantially Equivalent
K981975LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATEDLYYSubstantially Equivalent
K970794LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)LYYSubstantially Equivalent
K961602LATEX PATIENT EXAMINATION GLOVE (PINK)LYYSubstantially Equivalent
K961415LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION)LYYSubstantially Equivalent
K960942LATEX PATIENT EXAMINATION GLOVELYYSubstantially Equivalent
K954880LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION)LYYSubstantially Equivalent
K951018LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMERLYYSubstantially Equivalent
K946257LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC)LYYSubstantially Equivalent
K940022LATEX PATIENT EXAMINATION GLOVELYYSubstantially Equivalent
K923862LATEX PATIENT EXAMINATION GLOVE (POWDER FREE)LYYSubstantially Equivalent
K895642LATEX PATIENT EXAMINATION GLOVESOPESubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain