POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)

• K Number: K061551
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)
• Manufacturer: MEDIPURE CORPORATION (M) SDN. BHD.
• Date Cleared: 2006-08-24 ( 80 days)
• Product Code: LYY
• Regulation Number: 880.6250

Intended Use

The Powder Free Latex Examination Glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on hands or finger(s) for medical purposes to provide a barrier.against potentially infectious materials and other contaminants.

Device Description

The Powder Free Latex Examination Gloves. Natural or Blue Colour and with Protein Content Labeling Claim is equivalent to the exiting model, i.e. Latex Patient Examination Gloves. Powder Free which had submitted and cleared under 510(k) number K924356. The differences in this submission are: - With or without colour additive upon customers` preference or request. a) - With protein content labeling claim, i.e. "This latex glove contains 50 micrograms or b) less of total water extractable protein per gram``.

Predicate Devices

K924356

Reference Devices

K924356

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

Yes
The device is intended for "medical purposes to provide a barrier against potentially infectious materials and other contaminants," which aligns with the definition of a therapeutic device designed to prevent disease.

Diagnostic

No

The device is an examination glove, intended to provide a barrier against contaminants, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove made of latex, not software. The description focuses on material properties and performance testing related to a physical product.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is "intended to be worn on hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants." This describes a physical barrier device used on the body, not a device used to examine specimens in vitro (outside the body).
• Device Description: The description focuses on the physical characteristics of the glove (material, color, protein content) and its equivalence to a previously cleared examination glove. There is no mention of analyzing biological samples or providing diagnostic information.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing blood, urine, tissue, or other biological specimens.
  • Providing diagnostic, prognostic, or screening information.
  • Using reagents or assays.
  • Measuring analytes.

The device described is a medical glove, which is a Class I or Class II medical device depending on its intended use and risk, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Powder Free Latex Examination Glove, Natural or Blue Colour and with Protein Content Labeling Claim is a disposable device made of natural rubber latex and is intended to be worn on hands to provide barrier against potentially infectious materials and other contaminants on medical purposes.

The Powder Free Latex Examination Glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on hands or finger(s) for medical purposes to provide a barrier.against potentially infectious materials and other contaminants.

Product codes (comma separated list FDA assigned to the subject device)

80LYY

Device Description

The Powder Free Latex Examination Gloves. Natural or Blue Colour and with Protein Content Labeling Claim is equivalent to the exiting model, i.e. Latex Patient Examination Gloves. Powder Free which had submitted and cleared under 510(k) number K924356.

The differences in this submission are:

• With or without colour additive upon customers` preference or request. a)
• With protein content labeling claim, i.e. "This latex glove contains 50 micrograms or b) less of total water extractable protein per gram``.

All the above options will be subjected to design controls process, whereby risk assessment will be conducted to identify the potential hazards and estimate the risks of colour changed (Refer to Section 5 – Design Control Activities for the modified Device).

The modification of device does not affect the intended use of the device as well as it does not affect its safety and effectiveness.

The device description and comparison between unmodified and modified device, i.e. Powder Free Latex Examination Gloves. Natural or Blue Colour and with Protein Content Labeling Claim are as follows.

	Device Name
	Unmodified device	Modified Device
510 (K) Number	K924356	K061551
Device Listing Number	A722779	A722779
Proprietary Name	Multiple or Customers'
Trade Name	Safety + Comfort and
Multiple or Customers'
Trade Name
Product Code	80LYY	80LYY
Classification Name	Patient examination gloves.
powder free
(per 21 CFR 880.6251)	Patient examination gloves,
powder free
(per 21 CFR 880.6251)
Intended Use	Provide barrier against
potentially infectious
materials and other
contaminants	Provide barrier against
potentially infectious
materials and other
contaminants
Composition of gloves	Natural rubber latex	Natural rubber latex
Color Additive	Without color additive	With or without colour
additive
Protein Content Labeling
Claim	Without protein content
labeling claim	With protein content
labeling claim
Compliance with ASTM
standards	ASTM D3578
ASTM D6124	ASTM D3578
ASTM D6124
ASTM D5712
Compliance with other
standards	FDA 21 CFR 800.20	FDA 21 CFR 800.20
Labeling	21 CFR 820.120	21 CFR 820.120

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands or finger(s)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Characteristics	Standards	Device Name		Device
		Unmodified
device	Modified
Device	Performance
Palm Width
(Medium)	ASTM D 3578	90 - 91 mm	91 - 92 mm	Meets
Length (Medium)	ASTM D 3578	285 - 290 mm	285 - 292 mm	Meets
Finger Thickness
(Medium)	ASTM D 3578	0.31 - 0.32 mm	0.38 - 0.40	Meets
Palm Thickness
(Medium)	ASTM D 3578	0.25 - 0.26 mm	0.35 - 0.37 mm	Meets
Tensile Strength
(Unaged)	ASTM D 3578	19.04-32.10
MPa	22.88 - 30.87
MPa	Meets
Tensile Strength
(Aged)	ASTM D 3578	16.40 - 18.35
MPa	21.05 - 27.60
MPa	Meets
Freedom from
pinholes	ASTM D 3578
FDA 21 CFR
800.20	1/125	0/125	Meets
Visual Inspection

• Major defects | In-House
  Specification | 0/125 | 1/125 | Meets
  (AQL 2.5) |
  | Visual Inspection
• Minor defects | In-House
  Specification | 1/125 | 1/125 | Meets
  (AQL 4.0) |
  | Powder Residual | ASTM D 3578
  ASTM D 6124 | Avg. 1.63
  mg/glove | Avg. 0.96
  mg/glove. | Meets

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

K061551

AUG 2 4 2006

SPECIAL 510(k) SUMMARY

1.0 Modified Device Identification:

Trade Name	1) Safety + Comfort, and
	2) Multiple or Customers' Trade Name
Device Name	: Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 Micrograms or Less)
Common Name	: Examination Gloves
Classification Name	: Patient Examination Gloves (per 21 CFR 880.6251)

2.0 Submitter:

Name	: Medipure Corporation (M) Sdn Bhd
Address	: Lot 12, Medan Tasek, Tasek Industrial Estate, 31400 Ipoh. Perak
Darul Ridzuan. MALAYSIA
Phone #	: [phone]
Fax #	: [phone]
FDA Registration #	: 8041177
Device Listing #	: A722779

Date of Summary Prepared: May 24, 2006

3.0 Contact Person:

Name	: Mr. Terence Lim Sin Kooi
Phone #	: [phone]
Fax #	: [phone]

4.0 Identification of the Legally Marketed Device:

Class I powder free natural rubber latex examination gloves, 80LYY meets all the requirements of ASTM standard D 3578 - 05 and FDA 21 CFR 800.20.

5.0 Predicate Device Information:

Unmodified Device Name	: Latex Patient Examination Gloves, Powder Free
Cleared 510(k)	: K924356
Date Approved	: February 3, 1994

1

6.0 Description of Device Modification:

The Powder Free Latex Examination Gloves. Natural or Blue Colour and with Protein Content Labeling Claim is equivalent to the exiting model, i.e. Latex Patient Examination Gloves. Powder Free which had submitted and cleared under 510(k) number K924356.

The differences in this submission are:

• With or without colour additive upon customers` preference or request. a)
• With protein content labeling claim, i.e. "This latex glove contains 50 micrograms or b) less of total water extractable protein per gram``.

All the above options will be subjected to design controls process, whereby risk assessment will be conducted to identify the potential hazards and estimate the risks of colour changed (Refer to Section 5 – Design Control Activities for the modified Device).

The modification of device does not affect the intended use of the device as well as it does not affect its safety and effectiveness.

7.0 Intended Use of the Device:

The Powder Free Latex Examination Glove, Natural or Blue Colour and with Protein Content Labeling Claim is a disposable device made of natural rubber latex and is intended to be worn on hands to provide barrier against potentially infectious materials and other contaminants on medical purposes.

The indication for use and proposed labeling for the device are illustrated in sections 3 & 4.

8.0 Device Description and Comparison:

Access - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

The device description and comparison between unmodified and modified device, i.e. Powder Free Latex Examination Gloves. Natural or Blue Colour and with Protein Content Labeling Claim are as follows.

2

T	ab	0
		ﻟ	1
			***

	Device Name
	Unmodified device	Modified Device
510 (K) Number	K924356	K061551
Device Listing Number	A722779	A722779
Proprietary Name	Multiple or Customers'
Trade Name	Safety + Comfort and
Multiple or Customers'
Trade Name
Product Code	80LYY	80LYY
Classification Name	Patient examination gloves.
powder free
(per 21 CFR 880.6251)	Patient examination gloves,
powder free
(per 21 CFR 880.6251)
Intended Use	Provide barrier against
potentially infectious
materials and other
contaminants	Provide barrier against
potentially infectious
materials and other
contaminants
Composition of gloves	Natural rubber latex	Natural rubber latex
Color Additive	Without color additive	With or without colour
additive
Protein Content Labeling
Claim	Without protein content
labeling claim	With protein content
labeling claim
Compliance with ASTM
standards	ASTM D3578
ASTM D6124	ASTM D3578
ASTM D6124
ASTM D5712
Compliance with other
standards	FDA 21 CFR 800.20	FDA 21 CFR 800.20
Labeling	21 CFR 820.120	21 CFR 820.120

3

Table 2

Characteristics	Standards	Device Name		Device
		Unmodified
device	Modified
Device	Performance
Palm Width
(Medium)	ASTM D 3578	90 - 91 mm	91 - 92 mm	Meets
Length (Medium)	ASTM D 3578	285 - 290 mm	285 - 292 mm	Meets
Finger Thickness
(Medium)	ASTM D 3578	0.31 - 0.32 mm	0.38 - 0.40	Meets
Palm Thickness
(Medium)	ASTM D 3578	0.25 - 0.26 mm	0.35 - 0.37 mm	Meets
Tensile Strength
(Unaged)	ASTM D 3578	19.04-32.10
MPa	22.88 - 30.87
MPa	Meets
Tensile Strength
(Aged)	ASTM D 3578	16.40 - 18.35
MPa	21.05 - 27.60
MPa	Meets
Freedom from
pinholes	ASTM D 3578
FDA 21 CFR
800.20	1/125	0/125	Meets
Visual Inspection

• Major defects | In-House
  Specification | 0/125 | 1/125 | Meets
  (AQL 2.5) |
  | Visual Inspection
• Minor defects | In-House
  Specification | 1/125 | 1/125 | Meets
  (AQL 4.0) |
  | Powder Residual | ASTM D 3578
  ASTM D 6124 | Avg. 1.63
  mg/glove | Avg. 0.96
  mg/glove. | Meets