Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
Explanation: The device is a patient examination glove, intended to prevent contamination, not to treat or cure a disease or condition.

Diagnostic

No
Explanation: The device is a patient 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 rubber, intended to be worn on the hand. It describes physical properties and testing related to the material and form factor, not software.

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." This describes a barrier device used for infection control during physical examinations.
Device Description: The description focuses on the physical properties of the glove (material, tensile strength, watertightness) and its function as a barrier.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, instruments, or software used to analyze biological samples.
Performance Studies: The performance studies described focus on the physical integrity and biocompatibility of the glove, not on the accuracy or reliability of diagnostic results from analyzing biological samples.

Therefore, this device falls under the category of a medical device used for protection and infection control, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 patient and examiner

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

LZA

Device Description

The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical properties. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

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 tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

a) ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for Irritation and Skin Sensitization
b) ISO 10993-11- Biological Evaluation of Medical devices- Part 11: Tests for Systemic toxicity
c) ASTM D6124-06 (Reapproved 2017), Standard test method for Residual powder on medical gloves
d) ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in medical gloves
e) ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application

Performance data of gloves based on ASTM D6977 and FDA Watertight Test.
Biocompatibility Testing based on animal studies: i) Skin irritation in rabbits, Guinea pig sensitization (Buehler) and acute systemic cytotoxicity test were conducted on Novid PPE Sdn Bhd's final and finished Powder Free Blue Nitrile Examination Gloves.
Key results:

Pinhole Test (ASTM D 5151): Pass, AQL 1.5
Physical Properties (ASTM D6319): Pass (Before Aging: Tensile Strength Min 14 MPa, Elongation Min 500%; After Aging: Tensile Strength Min 14 MPa, Elongation Min 400%)
Watertight (1000mL) in accordance with ASTM D5151 (Leak Test): Pass G1 : AQL 2.5
Length (mm): S: 240mm minimum for all sizes, M: 240mm minimum for all sizes, L: 240mm minimum for all sizes, XL: 240mm minimum for all sizes.
Palm width (mm): S: 84 – 86, M: 95-96, L: 108 – 109, XL: 114 - 115
Thickness (mm) Single Layer: Finger Min 0.06, Palm Min 0.06, Cuff Min 0.05
Physical Properties in accordance with ASTM D412: Before Aging - Tensile Strength (MPa) 17 – 23, Ultimate Elongation (%) 540 – 607; After Aging - Tensile Strength (MPa) 21 – 27, Ultimate Elongation (%) 480 - 565
Powder Content in accordance with ASTM D6124: Below 2.0 mg/ glove
Guinea Pig Sensitization: No reaction was observed, conclusion meets conformance requirements.
Primary Dermal Irritation in Rabbits: Primary Irritation Index was 0, conclusion meets conformance requirements.
Acute Systemic Cytotoxicity in Rats: All animals survived, appeared healthy, gained body weight, and gross necropsies showed no abnormalities, conclusion meets conformance requirements.

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

ASTM D 5151 Pinhole Test: AQL 1.5
Watertight (1000mL) in accordance with ASTM D5151: Pass G1 : AQL 2.5
Powder Content in accordance with ASTM D6124: Max 2.0 mg/ glove
Primary Irritation Index from Primary Dermal Irritation in Rabbits: 0

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.

K172930

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). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 17, 2022

Novid PPE Sdn. Bhd. Er Chuan QA Manager Lot 6071, Jalan Haji Abdul Manan, Batu 5 1/2, Jalan Meru Klang, Selangor 41050 Malaysia

Re: K213107

Trade/Device Name: Powder Free Blue Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 7, 2021 Received: September 24, 2021

Dear Er Chuan:

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, PhD 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K213107

Device Name Powder Free Blue Nitrile Examination Gloves

Indications for Use (Describe)

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 patient and examiner

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K213107

510K Summary

As required by 21 CFR 807.92

1) Submission Information:

Date	: 18th September 2021
Type of 510(k) Submission	: Traditional
Basis for 510(k) Submission	: New Device
Applicant	: Novid PPE Sdn Bhd
Lot 6071, Jalan Haji Abdul Manan,
Batu 5 ½, Jalan Meru,
41050 Klang, Selangor, Malaysia
Contact Person	: Er Chai Chuan (QA Manager)
Lot 6123, Jalan Haji Salleh,
Batu 5 ½, Jalan Meru, 41050 Klang,
Selangor, Malaysia.
E-mail: chuan@notionventure.com
Tel: +6016 3689637

2) Device:

Proprietary Name: Powder Free Blue Nitrile Examination Gloves Classification Name: Examination Gloves Regulation Number: 880.6250 Product Code: LZA Device Class: I Review Panel: General Hospital

3) Device Description

The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical properties. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner.

4

4) Identification of the Legally Marketed Devices

Class 1 Nitrile Patient Examination Gloves LZA, powder free that meets all the requirements of ASTM standard D6319 and FDA water leak test.

5) The Intended Use of Gloves

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

Comparison of Technological Characteristics with the Predicate Device: Table 1: General Comparison

Technological characteristics Comparison to Predicate Device
	Subject Device	Predicate Device	Comparison
	Novid PPE Sdn Bhd's
Powder Free Blue
Nitrile Examination
Gloves	Mercator Medical
(Thailand) LTD's
mCare Powder Free
Nitrile Blue
Examination Gloves -
510K Number	K213107	K172930
Indications for Use	The device 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 device is a
disposable device
intended for medical
purposes that are worn
on the examiner's hand
to prevent
contamination between
patient and examiner.	Same
Design Specification	Meet ASTM D6319-10	Meet ASTM D6319-10	Same
Performance
Physical Properties	Meet ASTM D6319-10	Meet ASTM D6319-10	Same
Material of
Composition	Synthetic Nitrile
Rubber	Synthetic Nitrile
Rubber	Same
Biocompatibility:
Animal Irritation
Test Rabbit	Under the condition of
study, not an irritant	Under the condition of
study, not an irritant	Same
Dermal Sensitization
Test- Guinea Pig	Under the condition of
study, not a sensitizer	Under the condition of
study, not a sensitizer	Same
Acute Systemic
Cytotoxicity	Under the condition of
the study, no adverse
biological reaction	Under the condition of
the study, no adverse
biological reaction	Same
Color	Synthetic gloves with
embedded colorant-
Blue	Synthetic gloves with
embedded colorant-
Blue	Same
Sterility	Non-Sterile	Non-Sterile	Same

Powder Free	Meets applicable definition for Powder free; ≤ 2mg per glove	Meets applicable definition for Powder free; ≤ 2mg per glove	Same
Labelling
Information	Single Use indication, Powder free, device name, gloves size, quantity, Patient examination gloves, Non-sterile	Single Use indication, Powder free, device name, gloves size, quantity, Patient examination gloves, Non-sterile	Same
Physical
Properties
as per
ASTM
D6319-10	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
Dimension
as per
ASTM
D6319-10	Finger Thickness:
0.06 - 0.10 mm
Length: min 230 mm	Finger Thickness:
Min 0.05 mm Length:
min 230 mm	Similar
Freedom
from holes	AQL per CFR
21.800.20
Test as per ASTM
D5151	AQL per CFR
21.800.20
Test as per ASTM
D5151	Same
Residual
Powder	Tested to ASTM
D6124 and meets
requirement	Tested to ASTM
D6124 and meets
requirement	Same

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6) Non-clinical test was performed on the proposed device:

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

a) ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for Irritation and Skin Sensitization
b) ISO 10993-11- Biological Evaluation of Medical devices- Part 11: Tests for Systemic toxicity
c) ASTM D6124-06 (Reapproved 2017), Standard test method for Residual powder on medical gloves
d) ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in medical gloves
e) ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application

Performance data of gloves based on ASTM D6977 and FDA Watertight Test In addition the proposed device was tested and conformed to the following standards and requirements stated in guidance for industry passed and FDA staff - Premarket Notification [510(k)] Submission issued on March 5, 2004:

Table 2: Performance Testing Performance data of gloves and Biocompatibility Testing based on animal studies, biocompatibility studies i) Skin irritation in rabbits, Guinea pig sensitization (Buehler) and acute systemic cytotoxicity test were conducted on Novid PPE Sdn Bhd's final and finished Powder Free Blue Nitrile Examination Gloves.

| Test Method | Purpose | Acceptance
Criteria | Powder Free Blue Nitrile
Examination
Gloves Results |
|-------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| ASTM D 5151 | Pinhole Test | Free from holes,
AQL 1.5 | Pass |
| ASTM D6319 | Physical Properties | Before Aging
Tensile Strength:
Min 14 MPa
Elongation: Min
500%
After Aging
Tensile Strength:
Min 14 MPa
Elongation: Min
400% | Pass |

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| 1. Watertight (1000mL)
in accordance with
ASTM D5151 | Leak Test | Single Sampling
in accordance
with ISO 2859
G1 : AQL 2.5 | Pass G1 : AQL 2.5 | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Length (mm) Size | Physical Properties | | | |
| S | | Min 220 | 240mm minimum for all
sizes | |
| M | | Min 230 | | |
| L | | Min 230 | | |
| XL | | Min 230 | | |
| 3. Palm width (mm) Size | Physical Properties | | | |
| S | | 80 ± 10 | 84 – 86 | |
| M | | 95 ± 10 | 95-96 | |
| L | | 110 ± 10 | 108 – 109 | |
| XL | | 120 ± 10 | 114 - 115 | |
| 4. Thickness (mm)
Single Layer Finger | Physical Properties | | | |
| Palm | | Min 0.05 | Min 0.06 | |
| Cuff | | Min 0.05 | Min 0.06 | |
| | | Min 0.05 | Min 0.05 | |
| 5. Physical Properties in
accordance with ASTM D412 | Physical Properties | | | |
| Before Aging | | | | |
| Tensile Strength (MPa) | | Min 14 | 17 – 23 | |
| Ultimate Elongation (%) | | Min 500 | 540 – 607 | |
| After Aging | | | | |
| Tensile Strength (MPa) | | Min 14 | 21 – 27 | |
| Ultimate Elongation (%) | | Min 400 | 480 - 565 | |
| 6. Powder Content in accordance
with ASTM D6124 | Powder Residue | Max 2.0 mg/ glove | Below 2.0 mg/ glove | |
| I. Guinea Pig
Sensitization | This test was
designed to
determine if the
test article is a
potential sensitizer
to guinea pigs
when applied
atopically. | No deviations were
noted, observed
nor require
clarification. | No reaction was observed
upon removal of the test
material and there was no
positive allergic reaction
observed on the test of
guinea pigs during the
challenge phase. None of
the guinea pigs was
sensitized.
Conclusion: meets
conformance
requirements | |
| II. Primary Dermal | This test was
designed to | No deviations were
noted, observe nor | Each test was
individually | |
| | Irritation in Rabbits | identify substances which are primary irritants to rabbit skin | require clarification. | examined and scored at 24 $\pm$ 2,
48 $\pm$ 2 and 72 $\pm$ 2 hours for erythema and edema using the Draize skin scoring scale. Results obtained as Primary Irritation Index was 0. Conclusion: meets conformance requirements. |
| III. | Acute Systemic Cytotoxicity in Rats | This test was designed to identify any adverse biological reaction following administration of the extracts of the test item on the rats. | No adverse reaction was noted, observed nor require clarification. | For the 4 days observation done on the test subject by doing:

Cage- side observation- all animals survived and appeared healthy and active through out of 4 days.
Body weight- all animals gained body weight through out of the 4 days. |

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9

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		3) Pathology-
		At sacrifice
		times, gross
		necropsies
		showed no
		abnormalities
		for any of the
		animals.
		Conclusion:
		meets
		conformance
		requirements.

7) Clinical Test Conclusion

No clinical study is included in this submission

8) Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and perform as well as or better than the legally marketed predicated K172930.