FDA.reportPublic FDA data

Layer4

Primary DI
00850064227055
Brand
Layer4
Company
Usa Scientific, Inc.
Model
3915-3300
Catalog number
3915-3300
Device description
Layer4 Comfort Nitrile Exam Gloves Medium 200 per Box
Published
2024-05-07
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102790000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102790000POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUGPerusahaan Getah Asas Sdn. Bhd.2010-11-29LZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850064227055PackageGS110In Commercial Distribution
00850064227048PrimaryGS10
10850064227045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064227055008500642270558500642270550850064227055
00850064227048008500642270488500642270480850064227048
1085006422704510850064227045

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
352-237-6288info@usascientific.com

Regulatory Flags#

DUNS number
106947237
Device count
200
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850064227017Layer43915-11003915-11002024-05-07
00850064227024Layer43915-22003915-22002024-05-07
00850064227048Layer43915-33003915-33002024-05-07
00850064227062Layer43915-44003915-44002024-05-07
00850064227086Layer43915-55003915-55002024-05-07
00850064227109Layer43925-11003925-11002024-05-07
00850064227123Layer43925-22003925-22002024-05-07
00850064227147Layer43925-33003925-33002024-05-07
00850064227161Layer43925-44003925-44002024-05-07
00850064227185Layer43925-55003925-55002024-05-07
00850064227000Layer43915-11003915-11002024-05-07
00850064227031Layer43915-22003915-22002024-05-07
00850064227079Layer43915-44003915-44002024-05-07
00850064227093Layer43915-55003915-55002024-05-07
00850064227116Layer43925-11003925-11002024-05-07
00850064227130Layer43925-22003925-22002024-05-07
00850064227154Layer43925-33003925-33002024-05-07
10850064227168Layer43925-44003925-44002024-05-07
00850064227192Layer43925-55003925-55002024-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850061371246American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371260American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371284American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371291American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371307American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371314American Health and SafetyLabsource, Inc.LZC2026-11-02
10809160542118HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-28
10809160541722HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541746HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541753HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
10809160541470HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
10809160541487HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
10809160541494HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15