FDA.reportPublic FDA data

GORILLA

Primary DI
00816073022418
Brand
GORILLA
Company
Health Body World Supply Inc.
Model
G99
Catalog number
G99
Device description
Powder-Free Black Latex Glove Size Range xsmall to xlarge 100pcs per box, 10 boxes per case
Published
2018-04-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LYYLatex Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816073022412PackageGS110In Commercial Distribution
00816073022418PrimaryGS10
10816073022415Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081607302241220816073022412
00816073022418008160730224188160730224180816073022418
1081607302241510816073022415

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Device Sizes#

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

Regulatory Flags#

DUNS number
155986677
Device count
100
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816073022487SILVERSTARNo.30G x 100mm(4.0")S30402026-06-23
00816073023347HyChiNo.30G x 30mm (1.0")Y30102026-06-23
00816073023354HyChiNo.30G x 50mm (2.0")Y30202026-06-23
00816073023361HyChiNo.32G x 30mm (1.0")Y32102026-06-23
00816073023378HyChiNo.32G x 40mm (1.5")Y32152026-06-23
00816073023385HyChiNo.32G x 50mm (2.0")Y32202026-06-23
00816073023392HyChiNo.34G x 30mm (1.0")Y34102026-06-23
00816073023408HyChiNo.34G x 40mm (1.5")Y34152026-06-23
00816073023415HyChiNo.34G x 50mm (2.0")Y34202026-06-23
00816073023422HyChiNo.36G x 30mm (1.0")Y36102026-06-23
00816073023576SILVERSTARNo.44G x 13mm(0.5")S44052026-06-23
00816073023583SILVERSTARNo.44G x 25mm(1.0")S44102026-06-23
00816073023644HyChiNo.38G x 30mm (1.0")Y38102026-06-23
00816073023651HyChiNo.40G x 30mm (1.0")Y40102026-06-23
00816073023675HyChiNo.14G x 30mm (1.0")Y42102026-06-23
00816073023682HyChiNo.12G x 30mm (1.0")Y44102026-06-23
00816073023699HyChi - Mini 5No.32G x 15mm (0.5")Q32052026-06-23
00816073023705HyChi - Mini 5No.34G x 15mm (0.5")Q34052026-06-23
00816073023712HyChi - Mini 5No.36G x 15mm (0.5")Q36052026-06-23
00816073023729HyChi - Mini 5No.38G x 15mm (0.5")Q38052026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10076490456525TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456532TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
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10076490456556TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10810141931715VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931722VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931746VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931739VIVIT SupplyVivit Supply LLCLYY2024-05-17
09555002101053AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101060AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101077AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
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09555002101091AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101404AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101411AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101428AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101435AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101442AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101558AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101565AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101572AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101589AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101596AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
10810141931319VIVIT SupplyVivit Supply LLCLYY2023-12-22
10810141931326VIVIT SupplyVivit Supply LLCLYY2023-12-22
10810141931333VIVIT SupplyVivit Supply LLCLYY2023-12-22
10810141931340VIVIT SupplyVivit Supply LLCLYY2023-12-22
10810141931357VIVIT SupplyVivit Supply LLCLYY2023-12-22
G331COAP215S21Technigrip Powder Free Latex Exam GlovesTotal Source ManufacturingLYY2023-12-13
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