DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR

• K Number: K021536
• Device Name: DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR
• Manufacturer: WRP SPECIALTY PRODUCTS SDN. BHD.
• Date Cleared: 2002-06-10 ( 31 days)
• Product Code: LYY
• Regulation Number: 880.6250

Intended Use

The patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The patient examination glove may also provides additional protection in other areas where users are handling certain hazardous chemical such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

Device Description

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a patient examination glove, and the description focuses on material properties and performance standards, with no mention of AI or ML.

Therapeutic

No.
The device, a patient examination glove, is intended to prevent contamination and provide protection against hazardous chemicals, not to treat or cure a disease or condition.

Diagnostic

No

The device is a patient examination glove, intended to prevent contamination between patient and examiner and provide protection from certain hazardous chemicals. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a physical patient examination glove, not a software application. The description focuses on material properties and physical standards.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." It also mentions protection against certain hazardous chemicals. This describes a barrier device for personal protection and infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.
• Device Description: The description focuses on the physical properties and testing of the glove itself (dimensions, physical properties, freedom from pinholes, powder-free, protein level, biocompatibility, resistance to permeation). This aligns with a medical device for personal protection.
• Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information.

Therefore, this device falls under the category of a medical device, specifically a patient examination glove, and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The patient examination glove is a disposable device and is made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The patient examination glove may also provides additional protection in other areas where users are handling certain hazardous chemical such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

Product codes

LYY

Device Description

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner's

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

0

JUN 1 0 2002

K021536

510(k) Summary

1.0 Submitter:

. . . .

n

Name:	WRP Specialty Products Sdn Bhd.
Address:	Lot 11, Jalan 2, Kawasan Perushaan Bandar Baru Salak
Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
Phone No.:	[phone]
Fax No.:	[phone]

Date of Summary Prepared: 08 MAY 2002

2.0 Contact Person:

Name:	V. Nadarajan
Phone No.:	[phone]
Fax No.:	[phone]

3.0 Name of the device:

| Proprietary or Trade Name: | 1) Dermagrip, and
2) Multiple or Customer's Trade Name |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |
| Device Name: | Powder Free Latex Examination Gloves, Non-Sterile
with Protein Content Labeling Claim (50 Microgram
or less) and Tested for Use with Chemotherapy Drugs |

4.0 Identification of The Legally Marketed Device:

Class I patient examination gloves, 80LY, powder free, that meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.

5.0 Description of The Device:

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with_Chemotherapy Drugs meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.

1

6.0 Intended Use of the Device:

The patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

7.0 Summary of The Technological Characteristics of The Device:

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with Chemotherapy Drugs is summarized with the following technological characteristics compared to ASTM or equivalent standards.

Characteristics	Standards	Device Performance
Dimensions	ASTM D 3578 – 01EI	Meets
Physical Properties	ASTM D 3578 – 01EI	Meets
Freedom from pinholes	ASTM D 3578 – 01EI
FDA 21 CFR 800.20	Meets
Powder-Free	ASTM D 6124 – 01