FDA.reportPublic FDA data

Safehand

Primary DI
00810998039605
Brand
Safehand
Company
Winsight International Solutions, Inc.
Model
EM-PFNGL-N
Device description
M-PFNGL SAFEHAND glove NITRILE LARGE BLACK PWD FR 3.5MIL
Published
2022-12-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJGFlasher, Afterimage, Ophthalmic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810998039605PrimaryGS10
00810998039612Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810998039605008109980396058109980396050810998039605
00810998039612008109980396128109980396120810998039612

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.

Contacts#

Phone, Email table
PhoneEmail
909-438-7387phoebe.chen@dowellholding.com

Regulatory Flags#

DUNS number
079694430
Device count
1000
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810998039568SafehandEM-PFNGS-N2022-12-13
00810998039582SafehandEM-PFNGM-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
00810998034747SafehandEM-PFNGMEM-PFNGM2022-08-30

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
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
00810998035577SafehandWinsight 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