Predicate Devices

Reference Devices

No Reference Device(s) K/DEN number listed.

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and material properties of examination gloves, with no mention of AI or ML technologies.

Therapeutic

No
This device, Black Pearl Nitrile Examination Glove, is intended to prevent contamination between patient and examiner. Its purpose is protective and diagnostic in nature, not therapeutic.

Diagnostic

No

The device is an examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical glove made of nitrile, intended to be worn on the hand. It undergoes physical and biological testing, not software validation.

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 to prevent contamination between patient and examiner." This describes a barrier device used for personal protection and infection control.
IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
Lack of Diagnostic Function: The description of the Black Pearl Nitrile Examination Glove does not mention any function related to examining specimens from the human body or providing diagnostic information. Its purpose is purely a physical barrier.
Testing Performed: The performance studies described focus on the physical properties, safety, and barrier integrity of the glove (dimensions, freedom from holes, physical properties, biocompatibility tests). These are not tests related to in vitro diagnostic procedures.

Therefore, the Black Pearl Nitrile Examination Glove falls under the category of a general medical device, specifically a Class I or Class II device depending on the regulatory jurisdiction, but it is not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Black Pearl Nitrile Examination Glove is a disposable device, intended for medical purposes 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

Black Pearl Nitrile Examination Glove is a single use examination glove, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The nitrile glove is an ambidextrous, beaded cuff and black in colour. It meets the performance requirements in accordance with ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner (medical purposes)

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 non-clinical tests meets ASTM D6319-19 and ASTM D6124 -06 (Reapproved 2017) standards requirements.

Test Title: Dimensions

Device Description/Sample Size: Gloves sampled from the finished product and identified as Non-Sterile, Powder Free, Nitrile Examination Gloves, Black. The inspection level is S-2 and the acceptable quality level (AQL) is 4.0. The lot size for this sampling is 35,001 to 150,000. Therefore, 13 pieces of gloves from each size were used for the testing.
Test Method/Applicable Standard: ASTM D6319-19
Purpose of Testing: To measure the length, width, and thickness of gloves
Results: All glove sizes (XS, S, M, L, XL) passed the acceptance criteria for length, width, and thickness (Palm - Min. 0.05mm, Finger - Min. 0.05mm).

Test Title: Freedom From Holes

Device Description/Sample Size: Gloves sampled from the finished product and identified as Non-Sterile, Powder Free, Nitrile Examination Gloves, Black. The inspection level is G-1 and the acceptable quality level (AQL) is 2.5. The lot size for this sampling is 35,001 to 150,000. Therefore, 200 pieces of M-size gloves were used for the testing.
Test Method/Applicable Standard: ASTM D6319-19
Purpose of Testing: To detect holes that leak water and thereby compromise the usefulness of the gloves.
Results: During the test, 2 pieces were found with holes. The device passed the acceptance criteria (Accept: 10 pieces, Reject: 11 pieces).

Test Title: Physical Properties

Device Description/Sample Size: Gloves sampled from the finished product and identified as Non-Sterile, Powder Free, Nitrile Examination Gloves, Black. The inspection level is S-2 and the acceptable quality level (AQL) is 4.0. The lot size for this sampling is 35,001 to 150,000. Therefore, 13 pieces of M-size gloves were used for the testing.
Test Method/Applicable Standard: ASTM D6319-19
Purpose of Testing: To evaluate the physical property characteristics of gloves.
Results: Before Aging - Tensile Strength: Min. 18.2 MPa, Ultimate Elongation: Min. 500%. After Accelerated Aging - Tensile Strength: Min. 17.4 MPa, Ultimate Elongation: Min. 400%. The device passed the acceptance criteria.

Test Title: Powder-free Residue

Device Description/Sample Size: 5 pieces of gloves were sampled from the finished product and identified as Non-Sterile, Powder Free, Nitrile Examination Gloves, Black.
Test Method/Applicable Standard: ASTM D6124-06 (Reapproved 2017)
Purpose of Testing: To determine the amount of residual powder and non-powder solids found on gloves.
Results: 0.70mg/ glove. The device passed the acceptance criteria of ≤ 2.0mg/ glove.

Test title: Skin Irritation Test in New Zealand White Rabbits

Purpose of Testing: To determine the skin irritation potential of the Non-Sterile, Powder Free, Nitrile Examination Gloves, Black in New Zealand White rabbits.
Device Description: Non-Sterile, Powder Free, Nitrile Examination Gloves. Black is a non-sterile glove, intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner. It is a surface device which comes in contact with skin. The duration of contact is less than or equal to 24 hours.
Test Method: The test item extract was loaded on absorbent gauze and placed topically on the fur clipped area of six rabbits. Animals were observed for three consecutive days for morbidity, mortality, skin reactions and abnormal clinical signs and symptoms. Skin reactions were visually scored according to ISO 10993-23:2021(E) at 24, 48 and 72 h.
Results: No mortality or morbidity was observed. No local skin irritation was observed at the test site in any of the animals and the primary irritation index obtained was '0'.
Conclusion: The given test item, Non-Sterile, Powder Free, Nitrile Examination Gloves, Black, is considered as non-irritant under the conditions of the present study.

Test title: Skin Sensitization Test in Guinea Pigs

Purpose of Testing: To determine the skin sensitization potential of the Non-Sterile, Powder Free, Nitrile Examination Gloves, Black using guinea pig maximization test (GPMT).
Device Description: Non-Sterile, Powder Free, Nitrile Examination Gloves Black is a non-sterile glove, intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner. It is a surface device which comes in contact with skin. The duration of contact is less than or equal to 24 hours.
Test Method: The test item extract was applied to guinea pigs in a two-stage procedure with intradermal injections on day 0, followed by a topical patch exposure on day 7 for 48 h. On day 21, challenge patches were applied for 24 h. Skin reaction grading was performed using Magnusson and Kligman scale at 24h and 48 h, after removing the challenge patches according to ISO 10993-10:2010(E).
Results: No mortality or morbidity were observed. No skin sensitization reactions were observed in both control and test sites of all the animals.
Conclusion: The given test item, Non-Sterile, Powder Free, Nitrile Examination Gloves, Black, is considered as non-sensitizer to Guinea Pigs under the conditions of the present study.

Test title: Test for in vitro Cytotoxicity

Purpose of Testing: To evaluate the in vitro cytotoxic potential of the test item in L-929 mouse fibroblasts cells using elution method.
Device Description: Non-Sterile, Powder Free, Nitrile Examination Gloves, Black is a non-sterile glove, intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner. According to ISO 10993-1:2018, this is classified as a surface device contacting skin, for ≤ 24 hours (limited exposure).
Test Method: Test item extract was prepared and applied to L-929 mouse fibroblasts cells. The cell cultures were then incubated at 37 ± 1°C for 24 h with 5% CO2. After incubation, the cells were subjected to qualitative measurements viz., cytotoxicity was graded based on the morphology of the cells.
Results: The cultures treated with the test item extract at undiluted (neat extract) (100%), 1:2 dilution (50%), 1:4 dilution (25%), 1:8 dilution (12.5%) showed complete destruction of the cell layers (grade 4). However, at dilutions 1:16 dilution (6.25%) and 1:32 dilution (3.125%) did not show any cytotoxic response (grade 0).
Conclusion: The given test item, Non-Sterile, Powder Free, Nitrile Examination Gloves, Black is considered as cytotoxic in undiluted (neat extract) (100%), 1:2 dilution (50%) 1:4 dilution (25%) and 1:8 dilution (12.5%). Non-cytotoxic to L-929 cells in 1:16 dilution (6.25%) and 1:32 dilution (3.125%).

Test title: Acute Systemic Toxicity Test in Swiss Albino Mice

Purpose of Testing: To determine the acute systemic toxicity potential of the test item in Swiss albino mice.
Device Description: Non-Sterile, Powder Free, Nitrile Examination Gloves, Black is a non-sterile glove, intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner. According to ISO 10993-1:2018(E), this is a surface device which comes in contact with skin for ≤ 24 hours (limited exposure).
Test Method: The test item extract was injected intravenously and intraperitoneally into Swiss Albino mice. The animals were observed for three consecutive days for morbidity, mortality, body weight and for any abnormal clinical signs.
Results: No mortality or morbidity was observed. No signs of clinical toxicity or overt toxicity was observed in any of the animals.
Conclusion: The given test item, Non-Sterile, Powder Free, Nitrile Examination Gloves, Black did not induce any systemic toxicity in swiss albino mice under the conditions of the present study.

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

Not Found

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.

K112012

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

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

April 22, 2024

UG Global Resources Sdn. Bhd. Lee Mei Ling General Manager, OA Lot 62 & 63, Lorong Senawang 3/2, Kawasan Perindustrian Senawang, Seremban, Negeri Sembilan 70450 Malaysia

Re: K232319

Trade/Device Name: Black Pearl Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 12, 2024 Received: March 12, 2024

Dear Lee Mei Ling:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

1

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.

For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices

2

OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K232319

Device Name Black Pearl Nitrile Examination Glove

Indications for Use (Describe)

Black Pearl Nitrile Examination Glove is a disposable device, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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4

510(k) SUMMARY

K232319

1.0 Submitter:
Name	: UG Global Resources Sdn Bhd
Address	: Lot 62 & 63 Lorong Senawang 3/2,
Kawasan Perindustrian Senawang,
70450 Seremban, Negeri Sembilan,
Malaysia.
Phone No.	: 606-676 0450
Fax No.	: 606-679 5694
Contact Person	: Ms. Lee Mei Ling
Email	: meiling.lee@unigloves.com.my
Date of Preparation	: 19th April 2024

2.0 Name of the Device

Trade Name	: Black Pearl Nitrile Examination Glove
Common Name	: Non-Sterile, Powder Free, Nitrile Examination Gloves, Black
Classification Name	: Non-Powdered Patient Examination Glove (21 CFR 880.6250)
Class	: Class I
Product Code	: LZA

3.0 Identification of the Predicate Devices that equivalency is claimed:

Primary Predicate	: K112012, Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue
Company	: UG Healthcare (USA) Inc.
510(k)	: K112012
Classification Name	: Non-Powdered Patient Examination Glove (21 CFR 880.6250)
Class	: Class I
Product Code	: LZA

4.0 Description of the Device:

Black Pearl Nitrile Examination Glove is a single use examination glove, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The nitrile glove is an ambidextrous, beaded cuff and black in colour. It meets the performance requirements in accordance with ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

5

5.0 Intended Use of the Device

Black Pearl Nitrile Examination Glove is a disposable device, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

6.0 Comparison of Technological Characteristics Between the Subject Device and Predicate Device:

The Black Pearl Nitrile Examination Glove and predicate device are summarized with the following technological characteristics. Both gloves are made with nitrile and meets ASTM D6319-19 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.

The device has similar technological characteristics with the predicate device in terms of product code, intended use, indications for use, device material, additive, direction for use, construction, sterility, acceptance criteria, physical properties, biocompatibility test, residual powder test and freedom from holes. The technological characteristics differences between both devices are colour and dimensions. However, both colour pigment are with same intended use (colourant for nitrile products) and both dimensions are within ASTM D6319-19 standard. The comparison analysis is presented in the table below:

| Characteristic
and
parameters | Non-Sterile, Powder
Free, Nitrile
Examination Gloves
Blue
UG Healthcare (USA)
Inc. K112012
(Predicate) | Black Pearl Nitrile
Examination Glove
(K232319) | Comparison
Analysis | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|------|
| Product Code | LZA | LZA | Same | |
| Intended use | A 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
the patient and the
examiner. | Black Pearl Nitrile is a
disposable device,
intended for medical
purposes that is worn on
the examiner's hand to
prevent contamination
between patient and
examiner. | Same | |
| Indications for
Use | Non-Sterile, Powder
Free, Nitrile Examination
Gloves Blue is a
disposable device
intended for medical
purposes that is worn on
the examiner's hand to
prevent contamination
between patient and
examiner. | Black Pearl Nitrile is a
disposable device,
intended for medical
purposes that is worn on
the examiner's hand to
prevent contamination
between patient and
examiner. | Same | |
| Device Material | Nitrile | Nitrile | Same | |
| Colour | Blue | Black | Different | |
| | (Colourant for nitrile
products) | (Colourant for nitrile
products) | | |
| Additives | No flavour additive | No flavour additive | Same | |
| Direction for Use | Single Use Only | Single Use Only | Same | |
| Construction | Ambidextrous | Ambidextrous | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Acceptance
Criteria | ASTM D6319-10 | ASTM D6319-19 | Same | |
| Device Tolerance & Specifications: | | | | |
| Dimensions | Meets ASTM D6319-10
Thickness at Finger -
min. 0.05mm
Thickness at Palm -
min. 0.05mm | Meets ASTM D6319-19
Thickness at Finger -
min. 0.05mm
Thickness at Palm -
min. 0.05mm | Different | |
| | Overall Length -
240mm minimum | Length -
Size XS - min. 220mm
Size S - min. 220mm
Size M - min. 230mm
Size L - min. 230mm
Size XL - min. 230mm | | |
| | Width -
Size M - 95mm | Width -
Size XS - 70±10mm
Size S - 80±10mm
Size M - 95±10mm
Size L - 110±10mm
Size XL - 120±10mm | | |
| Physical
Properties | Meets ASTM D6319-10:
Tensile Strength: | Meets ASTM D6319-19:
Tensile Strength: | Same | |
| | Before
Aging | Before
Aging | | |
| | After
Aging | After
Aging | | |
| | Min. 14
MPa | Min. 14
MPa | | |
| | Ultimate Elongation: | Ultimate Elongation: | | |
| | Before
Aging | Before
Aging | | |
| | After
Aging | After
Aging | | |
| | min.
500% | min.
500% | | |
| | min.
400% | min.
400% | | |
| | | | | |
| Biocompatibility
Test | | | | |
| | a. Skin
Sensitization
Tests | Non-sensitizer under the
conditions of the study. | Non-sensitizer under the
conditions of the study. | Same |
| b. Irritation Tests | Non-irritant under the conditions of the study. | Non-irritant under the conditions of the study. | Same | |
| c. Cytotoxicity Test | Nil | Cytotoxic in undiluted (100%), 1:2 (50%), 1:4 (25%) and 1:8 dilution (12.5%). Non-cytotoxic to L-929 cells in 1:16 (6.25%) and 1:32 dilution (3.125%) | No test reports were submitted for predicate device | |
| d. Acute Systemic Toxicity | Nil | Did not induce any acute systemic toxicity in swiss albino mice under the conditions of the study. | No test reports were submitted for predicate device | |
| Residual Powder Test | Meets ASTM D6124-06: ≤ 2 mg/ glove | Meets ASTM D6124-06: ≤ 2 mg/ glove | Same | |
| Freedom from Holes | Meets ASTM D6319-10 Standard requirements | Meets ASTM D6319-19 Standard requirements | Same | |

6

Traditional 510(k) Premarket Notification

Trade name: Black Pearl Nitrile Examination Glove

Trade name: Black Pearl Nitrile Examination Glove
Common name: Non-Sterile, Powder Free, Nitrile Examination Gloves, Black

7

8

7.0 Summary of Non-Clinical Testing

The performance test data of non-clinical tests meets ASTM D6319-19 and ASTM D6124 -06 (Reapproved 2017) standards requirements.

| Test
Performed | Device Description/
Sample Size | Test Method/Applicable
Standard | Purpose of
Testing | Gloves
Size | Acceptance Criteria | | Results | | Status | |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------|
| Test Title:
Dimensions | Gloves sampled from
the finished product and
identified as
Non-Sterile,
Powder Free,
Nitrile
Examination
Gloves, Black.
The inspection
level is S-2
and the
acceptable
quality level
(AQL) is 4.0.
The lot size for
this sampling
is 35,001 to
150,000.
Therefore, 13
pieces of
gloves from
each size were
used for the
testing. | ASTM D6319-19 | To measure
the length,
width, and
thickness of
gloves | XS | Length | Min. 220mm | Min. 242mm | | Pass | |
| | | | | | Width | 70mm ±10mm | 77mm to 80mm | | Pass | |
| | | | | | Thickness | Palm - Min. 0.05mm
Finger - Min. 0.05mm | Palm - Min. 0.06mm
Finger - Min. 0.08mm | | Pass | |
| | | | | S | Length | Min. 220mm | Min. 244mm | | Pass | |
| | | | | | Width | 80mm ±10mm | 83mm to 86mm | | Pass | |
| | | | | | Thickness | Palm - Min. 0.05mm
Finger - Min. 0.05mm | Palm - Min. 0.06mm
Finger - Min. 0.08mm | | Pass | |
| | | | | M | Length | Min. 230mm | Min. 241mm | | Pass | |
| | | | | | Width | 95mm ±10mm | 96mm to 98mm | | Pass | |
| | | | | | Thickness | Palm - Min. 0.05mm
Finger - Min. 0.05mm | Palm - Min. 0.06mm
Finger - Min. 0.08mm | | Pass | |
| | | | | L | Length | Min. 230mm | Min. 240mm | | Pass | |
| | | | | | Width | 110mm ±10mm | 107mm to 110mm | | Pass | |
| | | | | | Thickness | Palm - Min. 0.05mm
Finger - Min. 0.05mm | Palm - Min. 0.06mm
Finger - Min. 0.09mm | | Pass | |
| | | | | XL | Length | Min. 230mm | Min. 241mm | | Pass | |
| | | | | | Width | 120mm ±10mm | 119mm to 124mm | | Pass | |
| | | | | | Thickness | Palm - Min. 0.05mm
Finger - Min. 0.05mm | Palm - Min. 0.06mm
Finger - Min. 0.09mm | | Pass | |
| Test
Performed | Device Description/
Sample Size | | Test Method/Applicable
Standard | Purpose of
Testing | | Acceptance Criteria | | Results | | Status |
| Test Title:
Freedom
From
Holes | Gloves sampled from the
finished product and
identified as Non-Sterile,
Powder Free, Nitrile
Examination Gloves,
Black.
The inspection level is G-
1 and the acceptable
quality level (AQL) is 2.5.
The lot size for this
sampling is 35,001 to
150,000. Therefore, 200
pieces of M-size gloves
were used for the testing. | | ASTM D6319-19 | To detect holes
that leak water
and thereby
compromise the
usefulness of the
gloves. | | Sample size: 200 pcs
Inspection level: G-I
AQL: 2.5
Accept: 10 pieces
Reject: 11 pieces | | During the test, 2 pieces were
found with holes. | | Pass |
| Test Title:
Physical
Properties | Gloves sampled from the
finished product and
identified as Non-Sterile,
Powder Free, Nitrile
Examination Gloves,
Black. The inspection
level is S-2 and the
acceptable quality level
(AQL) is 4.0. The lot size
for this sampling is 35,001
to 150,000. Therefore, 13
pieces of M-size gloves
were used for the testing. | | ASTM D6319-19 | To evaluate the
physical property
characteristics of
gloves. | | Before
Aging
Tensile
Strength:
Min. 14
MPa
Ultimate
Elongation:
Min. 500% | After
Accelerated
Aging
Tensile
Strength:
Min. 14
MPa
Ultimate
Elongation:
Min. 400% | Before Aging
Tensile
Strength:
Min. 18.2
MPa
Ultimate
Elongation:
Min. 500% | After
Accelerated
Aging
Tensile
Strength: Min.
17.4 MPa
Ultimate
Elongation:
Min. 400% | Pass |

9

| Test
Performed | Device Description/
Sample Size | Test
Method/Applicable
Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------|---------------|--------|
| Test Title:
Powder-
free
Residue | 5 pieces of gloves were
sampled from the finished
product and identified as
Non-Sterile, Powder Free,
Nitrile Examination Gloves,
Black. | ASTM D6124-06
(Reapproved 2017) | To determine
the amount of
residual
powder and
non-powder
solids found
on gloves. | ≤ 2.0mg/ glove | 0.70mg/ glove | Pass |

Test Performed	Purpose of Testing	Device Description	Test Method	Results	Conclusion
Test title: Skin
Irritation Test in
New Zealand
White Rabbits	To determine the
skin irritation
potential of the Non-
Sterile, Powder
Free, Nitrile
Examination Gloves,
Black in New
Zealand White
rabbits.	Non-Sterile, Powder
Free, Nitrile
Examination Gloves.
Black is a non-sterile
glove, intended for
medical purpose that
is worn on the
examiners hand to
prevent
contamination
between patient and
examiner. It is a
surface device which
comes in contact
with skin. The
duration of contact is
less than or equal to
24 hours.	The test item that was cut and used
for extraction was extracted using
physiological saline (polar solvent)
and cottonseed oil (non-polar solvent)
at 37 ± 1 °C for 72 h and 20 min
under sterile conditions. Solvent
controls were also subjected to the
similar extraction conditions.
The test item extracts (0.5 mL) was
loaded on the absorbent gauze and
placed topically on the fur clipped
area of six rabbits (3 animals each for
polar and non-polar extracts). The
patches were loosely held in contact
with the skin by semi-occlusive
dressing with means of non-irritant
adhesive tape for 24 h. The test sites
were marked with non-irritant
permanent ink.
Animals were observed for three
consecutive days for morbidity.
mortality, skin reactions and
abnormal clinical signs and
symptoms following the patch
removal. The skin reactions were
visually scored according to ISO
10993-23:2021(E) at 24, 48 and 72 h.	No mortality or morbidity was
observed in the experimental
animals. A gradual increase in
body weight was observed in all
the animals at the end of the
experiment. No signs of clinical
toxicity or overt toxicity was
observed in any of the animals.
Hence, gross pathology and
histopathology was not
performed. No local skin
irritation was observed at the
test site in any of the animals
and the primary irritation index
obtained was '0'.	Based upon the
results obtained in
this study and in
line with ISO
10993-
23:2021(E), the
given test item.
Non-Sterile.
Powder Free,
Nitrile
Examination
Gloves, Black, is
considered as
non-irritant under
the conditions of
the present study.
Test Performed	Purpose of Testing	Device Description	Test Method	Results	Conclusion
Test title: Skin
Sensitization Test
in Guinea Pigs	To determine the
skin sensitization
potential of the Non-
Sterile, Powder
Free, Nitrile
Examination Gloves,
Black using guinea
pig maximization test
(GPMT).	Non-Sterile, Powder
Free, Nitrile
Examination Gloves
Black is a non-sterile
glove, intended for
medical purpose that
is worn on the
examiners hand to
prevent
contamination
between patient and
examiner. It is a
surface device which
comes in contact
with skin. The
duration of contact is
less than or equal to
24 hours.	The test item that was cut and used
for extraction was extracted in
physiological saline (polar solvent)
and cottonseed oil (non-polar solvent)
at 37 ± 1 °C for 72 ± 2 h (Intradermal
induction - 72 h and 10 min, Topical
induction - 72 h and 05 min,
Challenge phase - 72 h and 10 min)
under sterile conditions. Solvent
controls were subjected to similar
extraction conditions.
Animals were divided into four
groups; G1 - five guinea pigs for polar
solvent control, G2 - ten guinea pigs
for polar test item extract, G3 - five
guinea pigs for non-polar solvent
control and G4 - ten guinea pigs for
non-polar test item extract. The fur
over the treatment sites was clipped
and shaved on the day of treatment,
prior to dosing on all the animals.
Induction of sensitization was a two-
stage procedure with intradermal
injections on day 0 (with Freund's
complete adjuvant (FCA), solvent
controls and extracts), followed by a
topical patch exposure on day 7 for
48 h.
On day 21, challenge patches were
applied for 24 h. Skin reaction
grading was performed using
Magnusson and Kligman scale at 24h
and 48 h, after removing the
challenge patches according to ISO
10993-10:2010(E).	No mortality or morbidity were
observed in any of the animals
used in this study. A gradual
increase in body weight was
observed in all the animals at
the end of the experiment. No
skin sensitization reactions were
observed in both control and test
sites of all the animals.
Therefore, no gross and
histopathological examination
were conducted.	Based upon the
results obtained in
this study and in
line with ISO
10993-
10:2010(E), the
given test item,
Non-Sterile,
Powder Free,
Nitrile
Examination
Gloves, Black, is
considered as
non-sensitizer to
Guinea Pigs
under the
conditions of the
present study.

10

Test Performed	Purpose of Testing	Device Description	Test Method	Results	Conclusion
Test title: Test for
in vitro
Cytotoxicity	To evaluate the in
vitro cytotoxic
potential of the test
item in L-929 mouse
fibroblasts cells
using elution method	Non-Sterile, Powder
Free, Nitrile
Examination Gloves,
Black is a non-sterile
glove, intended for
medical purpose that
is worn on the
examiners hand to
prevent
contamination
between patient and
examiner. According
to ISO 10993-
1:2018,
this is classified as a
surface device
contacting skin, for
≤ 24 hours (limited
exposure)	The test item (both inner and outer
surfaces) was cut and extracted at a
ratio of 6 cm2 per mL in extraction
medium at 37 ± 1 °C for 24 ± 2 h.
Test item was extracted in 12 mL of
extraction medium at 37 ± 1 °C for 24
h and 15 minutes under aseptic
condition. Negative control (both
sides) was extracted in 7 mL of
extraction medium at 37 ± 1 °C for 24
h and 15 minutes. Positive control
(both sides) was extracted in 7 mL of
extraction medium at 37 ± 1 °C for 24
h and 15 minutes. Vehicle control
(MEM 05) was also subjected to the
same extraction condition.
Exponentially growing L-929 mouse
fibroblasts cells were seeded in 96-
well plate at 1 x 104 cells per well.
After 24 h, 1x MEM supplemented
with 10% heat inactivated foetal
bovine serum and 1%
penicillin/streptomycin solution
(complete growth medium) was
removed and replaced with a series
of six different dilution of the test item
extract ((Undiluted (100%), 1:2
dilution (50%), 1:4 dilution (25%), 1:8
dilution (12.5%), 1:16 dilution (6.25%)
and 1:32 dilution (3.125%)), medium
blank, vehicle, positive and negative
control extract. The cell cultures
were then incubated at 37 ± 1°C for
24 h with 5% CO2. After incubation,
the cells were subjected to qualitative
measurements viz., cytotoxicity was
graded based on the morphology of
the cells.	The cultures treated with the test
item extract at undiluted (neat
extract) (100%), 1:2
dilution (50%), 1:4 dilution
(25%), 1:8 dilution (12.5%)
showed complete destruction
of the cell layers (grade 4).
However, at dilutions 1:16
dilution (6.25%) and 1:32
dilution (3.125%) did not show
any cytotoxic response (grade
0).	Based upon the
results obtained in
this study and in
line with ISO
10993-5:2009, it
is concluded that
the given test
item, Non-Sterile,
Powder Free,
Nitrile
Examination
Gloves, Black is
considered as
cytotoxic in
undiluted (neat
extract) (100%),
1:2 dilution (50%)
1:4 dilution (25%)
and
1:8 dilution
(12.5%). Non-
cytotoxic to L-929
cells in 1:16
dilution (6.25%)
and 1:32
dilution (3.125%).
Test Performed	Purpose of Testing	Device Description	Test Method	Results	Conclusion
Test title: Acute
Systemic Toxicity
Test in Swiss
Albino Mice	To determine the
acute systemic
toxicity potential of
the test item in
Swiss albino mice.	Non-Sterile, Powder
Free, Nitrile
Examination Gloves,
Black is a non-sterile
glove, intended for
medical purpose that	The test item that was cut and used
for extraction was extracted at a ratio
of 6 cm2/mL of polar solvent
(physiological saline) as well as non-
polar solvent (cottonseed oil) at 37 ±
1 °C for 72 h and 18 minutes. Solvent	No mortality or morbidity was
observed in test item extracts
administered animals. A gradual
increase in body weight was
observed in all the animals at
the end of experiment. No clinical	Based upon the
results obtained
and in line with
ISO 10993-
11:2017(E), it is
concluded that

| Systemic Toxicity
Test in Swiss
Albino Mice | acute systemic
toxicity potential of
the test item in
Swiss albino mice. | Free, Nitrile
Examination Gloves,
Black is a non-sterile
glove, intended for
medical purpose that
is worn on the
examiners hand to
prevent
contamination
between patient and
examiner. According
to ISO 10993-
1:2018(E), this is a
surface device which
comes in contact
with skin for ≤ 24
hours (limited
exposure). | for extraction was extracted at a ratio
of 6 cm2/mL of polar solvent
(physiological saline) as well as non-
polar solvent (cottonseed oil) at 37 ±
1 °C for 72 h and 10 minutes. Solvent
controls were also subjected to the
same temperature and time
conditions.
Four groups of mice, each comprising
of five males were used for this study.
Two groups (G1 and G2) were
treated intravenously with polar
solvent control and polar extract,
respectively at a dose volume of 50
mL/kg body weight in two divided
doses at an interval of 1 h and 35
minutes within a 24 h period. Another
two groups (G3 and G4) were treated
intraperitoneally with non-polar
solvent control and non-polar extract
respectively at a dose volume of 50
mL/kg body weight in a single dose.
The animals were observed for three
consecutive days for morbidity,
mortality, body weight and for any
abnormal clinical signs and | observed in test item extracts
administered animals. A gradual
increase in body weight was
observed in all the animals at
the end of experiment. No signs
of clinical toxicity or overt toxicity
was observed in any of the
animals; hence, gross pathology
and histopathology was not
performed. | results obtained
and in line with
ISO 10993-
11:2017(E), it is
concluded that
the given test
item, Non-Sterile,
Powder Free,
Nitrile
Examination
Gloves, Black did
not induce any
systemic toxicity
in swiss albino
mice under the
conditions of the
present study. |

---------------------------------------------------	-----------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

11

8.0 Clinical Testing Summary

Not applicable - Clinical data is not needed for gloves.

9.0 Conclusion

The conclusion drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.