Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple examination glove and the summary contains no mention of AI or ML.

Therapeutic

No
The device, a nitrile examination glove, is intended for preventing contamination between patient and examiner, which is a barrier function, not a therapeutic one.

Diagnostic

No
The device, GLOVMASTER Nitrile Examination Glove Powder Free, is described as a disposable device worn on the examiner's hand to prevent contamination. Its function is to provide a barrier, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical glove made from acrylonitrilebutadiene copolymer dispersion, intended to be worn on the hand. It is a tangible hardware device, not software.

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 "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
Device Description: The description details the material, specifications, and classification (Class I, product code LZA). This classification and product code are for medical gloves, not IVD devices.
Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information about a patient's health status.
Performance Studies: The performance studies focus on the physical properties, barrier function, and biocompatibility of the glove, which are relevant to its intended use as a protective barrier. They do not involve diagnostic accuracy metrics.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any of those functions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

GLOVMASTER Nitrile Examination Glove Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

LZA

Device Description

GLOVMASTER Nitrile Examination Glove Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

examiner's hand

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)

Non-Clinical Data:
Performance Tests: GLOVMASTER Nitrile Examination Glove Powder Free was subjected to performance tests according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual. These tests included:

Dimension (length, width, thickness)
Physical property (tensile strength, ultimate elongation)
Barrier property tests (Detection of Holes in Medical Gloves)
Powder Free Residue
All tests found the device to be safe and efficient with respect to its intended use, meeting the specified acceptance criteria for each test.

Biocompatibility: The materials used were evaluated for biocompatibility based on the Guidance for Industry and FDA Staff - Medical Glove Guidance Manual, performing tests according to ISO 10993-1:2018. The tests performed were:

In vitro Cytotoxicity: The device extract has a cytotoxic potential.
Skin Sensitization: Not a sensitizer.
Skin Irritation: Not an irritant.
Acute Systemic Toxicity: Device extracts do not pose a systemic toxicity.
Material-Mediated Pyrogenicity: Did not demonstrate a non-pyrogenic response.

Sterilization: Not conducted as the product is non-sterile.
Shelf Life: Not claimed.

Clinical Test Data: Not conducted, as clinical data is not needed for this device.

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

Performance test results:

Dimensions (Length, Width, Thickness) for sizes S, M, L, XL all passed the specified minimums.
- E.g., for size S: Length 248 mm (Min 230mm); Width 85.61 mm (Min 80mm±10); Palm Thickness 0.07 mm (Min 0.05mm); Finger Thickness 0.11 mm (Min 0.05mm).
Physical Property (Tensile Strength, Ultimate Elongation):
- Tensile Strength: All sizes passed the 14MPa Min for pre and post aging. E.g., for size S: 33.60 MPa (Before Aging), 30.56 MPa (After Aging).
- Ultimate Elongation: All sizes passed the 500% Min for before aging and 400% Min for after aging. E.g., for size S: 521.53% (Before Aging), 483.84% (After Aging).
Barrier property test (Detection of Holes): AQL 2.5 Passed.
Powder Free Residue test: All sizes passed the ≤ 2Mg/Glove criteria. E.g., for size S: 0.04 mg/glove.

Biocompatibility Test Results:

In Vitro Cytotoxicity: "Under the conditions of the study, the device extract has a cytotoxic potential"
Skin Sensitization: "Under the conditions of the study not a sensitizer"
Skin Irritation: "Under the condition of study not an irritant"
Acute Systemic Toxicity: "Under the condition of study, the device extracts do not pose a systemic toxicity."
Material-Mediated Pyrogenicity: "Under the conditions of the study, the device demonstrate a non-pyrogenic response."

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K192333

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 22, 2021

Glovmaster SDN. BHD. % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive Suite 114 Aurora, Illinois 60504

Re: K212914

Trade/Device Name: Glovmaster Nitrile Examination Glove Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 17, 2021 Received: November 29, 2021

Dear Manoj Zacharias:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K212914

Device Name

GLOVMASTER Nitrile Examination Glove Powder Free

Indications for Use (Describe)

GLOVMASTER Nitrile Examination Glove Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)

Remediation Use (Ref 21 CFR 201.Subject D)
Own-Use/Third-Party Use (21 CFR 201.Subject G)

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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3

Image /page/3/Picture/0 description: The image shows the logo for Glovmaster. The logo consists of a globe with a hand reaching out to it on the left, followed by the word "GLOVMASTER" in large, bold letters. Below the word "GLOVMASTER" are the words "Life, Safe, Health" in a smaller font.

GLOVMASTER SDN. BHD (1390380-A)

Head Quarters: BV05F20, IOI Boulevard, Jalan Kenari 5, Bandar Puchong Jaya, 47100 Puchong Selangor Tel : 603-86034781

Manufacturing: 154, Jalan 4, Kawasan Perindustrian Olak Lempit, 42700 Banting, Selangor.

510(k) SUMMARY (K212914)

[AS REQUIRED BY 21CFR807.92]

I. SUBMITTER

510(k) Owner's Name	:	Glovmaster SDN. BHD.
Address	:	154, Jalan 4, Kawasan Perindustrian Olak Lempit, 42700
Banting, Selangor, Malaysia.
Telephone	:	+603-86034781
Contact person	:	Ms. Zarina binti Hamid
Designation	:	QMS Manager
Contact Number	:	+6013-5928225
Contact Email	:	ina@glovmaster.com.my
Date of Summary Prepared	:	21.12.2021

II. DEVICE

Device Name	:	GLOVMASTER Nitrile Examination Glove Powder Free
Device Common Name	:	Nitrile Examination Glove Powder Free
Device Classification name	:	Non-powdered patient examination glove
Regulation Number	:	21 CFR 880.6250
Class	:	I
Product Code	:	LZA

III. PREDICATE DEVICE

Predicate Device Name	:	JR Medic Blue Nitrile Examination Gloves Powder Free
510(k) Number	:	K192333
Regulation Number	:	21 CFR 880.6250
Class	:	I
Product Code	:	LZA

4

IV. DEVICE DESCRIPTION

GLOVMASTER Nitrile Examination Glove Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.

INDICATIONS FOR USE V.

GLOVMASTER Nitrile Examination Glove Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| SI.

No	Features compared	Proposed Device	Predicate Device	Comparison
	General Information
1.	510(k) Number	K212914	K192333	-
2.	Manufacturer	Glovmaster SDN. BHD.	JR Engineering & Medical
Technologies (M) SDN.BHD	-
3.	Classification	I	I	Same
4.	Regulation number	21 CFR 880.6250	21 CFR 880.6250	Same
5.	Product Code	LZA	LZA	Same
6.	Indication For Use	GLOVMASTER Nitrile Examination
Glove Powder Free is a disposable
device intended for medical
purpose that is worn on the
examiner's hand to prevent
contamination between patient
and examiner.	JR Medic Blue Nitrile Examination
Gloves Powder Free is disposable
devices intended for medical
purpose that are worn on the
examiner's hand to prevent
contamination between patient
and examiner.	Same
7.	Material	Nitrile	Nitrile	Same
8.	Color	Blue	Blue	Same
9.	Texture	Finger Texture	Finger texture	Same
10.	Ambidextrous	Yes	Data Not available	-
11.	Size	S, M, L, XL	XS, S, M, L, XL	Similar
12.	OTC Use	Yes	Yes	Same
13.	Reusability	Single use	Single use	Same
14.	Sterility	Non- sterile	Non- sterile	Same

Table 1: General Comparison

5

| SI.

No	Features compared	Proposed Device	Predicate Device	Comparison
15.	Dimensions	Length Min 230 m
Width Min 95±10
Mm (for medium size)	Length Min 230 m
Width Min 95±10
Mm (for medium size)	Same
16.	Thickness	Palm min 0.05 mm
Finger min 0.05 mm	Palm min 0.05 mm
Finger min 0.05 mm	Same
17.	Physical Properties	Before Aging
Tensile Strength min 14 MPa
Ultimate Elongation Min 500%
After Aging
Tensile Strength min 14 MPa
Ultimate Elongation Min 400%	Before Aging
Tensile Strength min 14 MPa
Ultimate Elongation Min 500%
After Aging
Tensile Strength min 14 MPa
Ultimate Elongation Min 400%	Same
18.	Detection of Holes	Passes AQL 2.5	Passes AQL 1.5	Similar
19.	Powder Free Residue	≤2 mg/glove	≤2 mg/glove	Same
20.	Biocompatibility Study	In Vitro Cytotoxicity	Under the conditions of the study, the device extract has a cytotoxic potential.	Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern.	Same
		Skin Sensitization	Under the conditions of the study not a sensitizer	Under the conditions of the study not a sensitizer	Same
		Skin Irritation	Under the condition of study not an irritant	Under the condition of study not an irritant	Same
		Acute systemic toxicity	Under the condition of study, the device extracts do not pose a systemic toxicity.	Under the condition of study, the device extracts do not pose a systemic toxicity.	Same
		Material mediated pyrogenicity	Under the conditions of the study, the device demonstrate a non-pyrogenic response.	Under the conditions of the study, the device did not demonstrate a material mediated Pyrogenicity response.	Same

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods.

VII. PERFORMANCE DATA

Non- Clinical Data A.

Performance Tests 1.

GLOVMASTER Nitrile Examination Glove Powder Free is subjected to the following performance tests according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual and found to be safe and efficient with respect to its intended use:

Dimension
Physical property
Barrier property tests Detection of Holes in Medical Gloves
Powder Free Residue

6

| SL
no | Title of
Test | Purpose
of Test | Reference
Source | Acceptance Criteria | | | Result | | | Pass/
Fail |
|----------|-------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------|-------------------------------|-------------------------------|---------------------|--------------|--------------|---------------|
| 1 | Physical
dimension
test | To
measure
the length,
width and
thickness
of gloves | ASTM
D6319-19
Standard
Specification
for Nitrile
Examination
Gloves for
Medical
Application | Size | Length | Width | Size | Length | Width | |
| | | | | S | 230mm
min | 80
mm±10 | S | 248 mm | 85.61
mm | Pass |
| | | | | M | | 95
mm±10 | M | 245.23
mm | 95.15
mm | Pass |
| | | | | L | | 110
mm±10 | L | 248.07
mm | 105 mm | Pass |
| | | | | XL | | 120
mm±10 | XL | 251.46
mm | 114.07
mm | Pass |
| | | | | Thickness | | | Thickness | | | Pass/
Fail |
| | | | | S | 0.05 mm
min | 0.05 mm
min | S | 0.07 mm | 0.11 mm | Pass |
| | | | | M | | | M | 0.06 mm | 0.11 mm | Pass |
| | | | | L | | | L | 0.06 mm | 0.11 mm | Pass |
| | | | | XL | | | XL | 0.06 mm | 0.10 mm | Pass |
| | | | | Tensile strength | | | Tensile strength | | | Pass/
Fail |
| | | To test
tensile
strength
and
ultimate
elongation | ASTM
D6319-19
Standard
Specification
for Nitrile
Examination
Gloves for
Medical
Application | S | 14Mpa
Min for
all sizes | 14Mpa
Min for
all sizes | S | 33.60
MPa | 30.56
MPa | Pass |
| 2 | Physical
property
test | | | M | | | M | 33.69
MPa | 32.05
MPa | Pass |
| | | | | L | | | L | 32.78
MPa | 28.66
MPa | Pass |
| | | | | XL | | | XL | 33.96
MPa | 32.20
MPa | Pass |
| | | | | Ultimate Elongation | | | Ultimate Elongation | | | Pass/
Fail |
| | | | | S | 500%
Min for
all sizes | 400%
Min for
all sizes | S | 521.53% | 483.84% | Pass |
| | | | | M | | | M | 553.07% | 514.61% | Pass |
| | | | | L | | | L | 526.15% | 504.61% | Pass |
| | | | XL | | | XL | 524.61% | 496.15% | Pass | |

Table 2: Performance Testing Summary

7

| SL
no | Title of
Test | Purpose
of Test | Reference
Source | Acceptance Criteria | Result |
|----------|-----------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3 | Barrier
property
test | To detect
holes in
gloves | ASTM
D6319-19 /
ASTM
D5151-19
Standard
Test Method
for Detection
of Holes in
Medical
Gloves | AQL 2.5 | AQL 2.5
Pass |
| 4 | Powder
free
residue
test | To test
residual
powder on
gloves | ASTM
D6124-06
(Reapproved
2017)
Standard
Test Method
for Residual
Powder on
Medical
Gloves | Size
S
M
L
XL | Residual powder
content
≤ 2Mg/ Glove
Size Residual powder content Pass/Fail
S 0.04 mg/glove Pass
M 0.30 mg/glove Pass
L 0.20 mg/glove Pass
XL 0.28 mg/glove Pass |

2. BIOCOMPATIBILITY

The materials used in the GLOVMASTER Nitrile Examination Glove Powder Free are biocompatible based on the biocompatibility tests mentioned in the Guidance for Industry and FDA Staff - Medical Glove Guidance Manual:

In vitro Cytotoxicity
Skin Sensitization
Skin Irritation
Acute Systemic Toxicity
Material-Mediated Pyrogenicity

These tests are performed according to ISO 10993-1:2018, Biological Evaluation of Medical Devices -Part 1, Evaluation and Testing within a Risk Management Process.

Table 3: Biocompatibility Test Summary
----------------------------------------	--

| SL
no | Title of Test | Purpose of
Test | Reference
Source | Acceptance
Criteria | Result |
|----------|--------------------------|---------------------------------------------|-----------------------|------------------------|---------------------------------------------------------------------------------------|
| 1 | In Vitro
Cytotoxicity | | ISO 10993-
5:2009 | Non cytotoxic | Under the conditions of the study,
the device extract has a
cytotoxic potential |
| 2 | Skin
Sensitization | To ensure the
device is
biocompatible | ISO 10993-
10:2010 | Non sensitizer | Under the conditions of the study not a
sensitizer |
| 3 | Skin Irritation | | ISO 10993-
10:2010 | Non irritant | Under the condition of study not an
irritant |

8

| SL
no | Title of Test | Purpose of
Test | Reference
Source | Acceptance
Criteria | Result |
|----------|---------------------------------------|----------------------------|--------------------------|------------------------|-------------------------------------------------------------------------------------------|
| 4 | Acute
Systemic
Toxicity | To ensure the
device is | ISO 10993-
11:2017 | Non toxic | Under the condition of study, the
device extracts do not pose a systemic
toxicity. |
| 5 | Material-
Mediated
Pyrogenicity | device is
biocompatible | ISO 10993-
11:2017(E) | Non pyrogenic | Under the conditions of the study, the
device demonstrate a non-pyrogenic
response. |

3. STERILISATION

Sterilization study was not conducted as GLOVMASTER Nitrile Examination Glove Powder Free is provided non-sterile.

4. SHELF LIFE

Shelf life is not claimed for GLOVMASTER Nitrile Examination Glove Powder Free.

B. CLINICAL TEST DATA

Clinical study was not conducted, as clinical data is not needed for GLOVMASTER Nitrile Examination Glove Powder Free.

VIII. CONCLUSION

The conclusion drawn from the non-clinical tests demonstrate that the subject device, GLOVMASTER Nitrile Examination Glove Powder Free are as safe, as effective and perform as well as or better than legally marketed predicated device in K192333.