510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Grand Work Plastic Products Co., Ltd.

ZANHUANG Hebei, CN

GRAND WORK PLASTIC PRODUCTS CO., LTD. appears in FDA device records in ZANHUANG Hebei, CN. FDA records list 19 510(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
19
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 19 510(k) clearances for Grand Work Plastic Products Co., Ltd. between 2004 and 2023. The busiest year on record is 2004, with 6. The most recent is 2023, with 3.

Clearances by year, as a table
510(k) clearance decisions for Grand Work Plastic Products Co., Ltd., by decision year
YearClearances
20046
20051
20061
20102
20141
20225
20233
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsKGOSubstantially Equivalent
K232039Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZASubstantially Equivalent
K230217Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy DrugsKGOSubstantially Equivalent
K222892Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy DrugsLZASubstantially Equivalent
K213574Nitrile Vinyl Blend Powder Free Examination Gloves (Black)LZASubstantially Equivalent
K220249Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)LZASubstantially Equivalent
K220250Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy DrugsLZASubstantially Equivalent
K220240Vinyl Co-Polymer Powder-free Examination Gloves, BlackLYZSubstantially Equivalent
K142409Vinyl Co-Polymer Powder Free Examination GlovesLYZSubstantially Equivalent
K102089GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVESLYZSubstantially Equivalent
K102094POWDER FREE VINYL PATIENT EXAMINATION GLOVESLYZSubstantially Equivalent
K061562VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLORLYZSubstantially Equivalent
K051662VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR)LZASubstantially Equivalent
K042830POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVESLYZSubstantially Equivalent
K040682SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREELYZSubstantially Equivalent
K041225SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWEREDLYZSubstantially Equivalent
K040681SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREELYZSubstantially Equivalent
K041188GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDEREDLYZSubstantially Equivalent
K040702SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREELYZSubstantially Equivalent

Registered establishments

FDA registered establishments for Grand Work Plastic Products Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30041687863004168786GRAND WORK PLASTIC PRODUCTS CO., LTD.DONGGAO INDUSTRIAL ZONE, ZANHUANG Hebei 050000 CN2026

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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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