FDA.reportPublic FDA data

Safehand

Primary DI
00810998035577
Brand
Safehand
Company
Winsight International Solutions, Inc.
Model
EM-PFNGXL
Catalog number
EM-PFNGXL
Device description
EM-PFNGL SAFEHAND GLV NITRILE EXTRA LARGE BLACK PWD FR, 3.5MIL
Published
2022-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NJGFlasher, Afterimage, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJGFlasher, Afterimage, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141303000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141303000ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLORZhida Glove Co., Ltd.2014-12-12LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810998035560PrimaryGS10
00810998035577Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810998035560008109980355608109980355600810998035560
00810998035577008109980355778109980355770810998035577

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079694430
Device count
1000
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810998039568SafehandEM-PFNGS-N2022-12-13
00810998039582SafehandEM-PFNGM-N2022-12-13
00810998039605SafehandEM-PFNGL-N2022-12-13
00810998039629SafehandEM-PFNGXL-N2022-12-13
00810998039278DHGDNGB-MDNGB-M2022-08-29
00810998039292DHGDNGB-LDNGB-L2022-08-29
00810998039315DHGDNGB-XLDNGB-XL2022-08-29
00810998034716SafehandEM-PFNGSEM-PFNGS2022-08-30
00810998034730SafehandEM-PFNGMEM-PFNGM2022-08-30
00810998034754SafehandEM-PFNGLEM-PFNGL2022-08-30
00810998035560SafehandEM-PFNGXLEM-PFNGXL2022-08-30
00810998039483SafehandBZ-30732BZ-307322022-08-30
00810998039506SafehandBZ-30756BZ-307562022-08-30
00810998039520SafehandBZ-30770BZ-307702022-08-30
00810998039544SafehandBZ-30794BZ-307942022-08-30
00810998039575SafehandEM-PFNGS-N2022-12-13
00810998039599SafehandEM-PFNGM-N2022-12-13
00810998039612SafehandEM-PFNGL-N2022-12-13
00810998039636SafehandEM-PFNGXL-N2022-12-13
00810998034723SafehandEM-PFNGSEM-PFNGS2022-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810998039568SafehandWinsight International Solutions, Inc.NJG2022-12-13
00810998039582SafehandWinsight International Solutions, Inc.NJG2022-12-13
00810998039605SafehandWinsight International Solutions, Inc.NJG2022-12-13
00810998039629SafehandWinsight International Solutions, Inc.NJG2022-12-13
00810998039575SafehandWinsight International Solutions, Inc.NJG2022-12-13
00810998039599SafehandWinsight International Solutions, Inc.NJG2022-12-13
00810998039612SafehandWinsight International Solutions, Inc.NJG2022-12-13
00810998039636SafehandWinsight International Solutions, Inc.NJG2022-12-13
00810998034716SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998034730SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998034754SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998035560SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998039483SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998039506SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998039520SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998039544SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998034723SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998034747SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998034761SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998039490SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998039513SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998039537SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998039551SafehandWinsight International Solutions, Inc.NJG2022-08-30
00810998039278DHGWinsight International Solutions, Inc.NJG2022-08-29
00810998039292DHGWinsight International Solutions, Inc.NJG2022-08-29
00810998039315DHGWinsight International Solutions, Inc.NJG2022-08-29
00810998039285DHGWinsight International Solutions, Inc.NJG2022-08-29
00810998039308DHGWinsight International Solutions, Inc.NJG2022-08-29
00810998039322DHGWinsight International Solutions, Inc.NJG2022-08-29