510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Shun Thai Rubber Gloves Industry Public Co., Ltd.

MUANG Rayong, TH

SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. appears in FDA device records in MUANG Rayong, TH. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 6 510(k) clearances for Shun Thai Rubber Gloves Industry Public Co., Ltd. between 2004 and 2010. The busiest year on record is 2004, with 2. The most recent is 2010, with 1.

Clearances by year, as a table
510(k) clearance decisions for Shun Thai Rubber Gloves Industry Public Co., Ltd., by decision year
YearClearances
20042
20052
20061
20101
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K092617ROYAL GUARDLZASubstantially Equivalent
K060229POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTELYYSubstantially Equivalent
K052030SURGEON'S GLOVE, POWDER FREEKGOSubstantially Equivalent
K052031POWDERED LATEX SURGEON'S GLOVEKGOSubstantially Equivalent
K040406POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)LYYSubstantially Equivalent
K040408POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)LYYSubstantially Equivalent

Registered establishments

FDA registered establishments for Shun Thai Rubber Gloves Industry Public Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
80408181000154563SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.9 MOO 4 KACHED, MUANG Rayong 21100 TH2026

Registration numbers link to the FDA registration and listing record for that establishment.

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