Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple examination glove and the description focuses on material properties and standard compliance, with no mention of AI/ML.

Therapeutic

No
The device, examination gloves, is intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.

Diagnostic

No
Explanation: The device is an examination glove, intended to prevent contamination between patient and examiner. It does not provide any diagnostic information or analysis.

SaMD (Software as a Medical Device)

No

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

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 "to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
Device Description: The description clearly states it's a "disposable device intended for medical purpose that is worn on the examiner's hand." It's classified as a Class I patient examination glove.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
Performance Studies: The performance studies focus on physical properties (strength, freedom from holes) and biocompatibility, which are relevant to a barrier device, not a diagnostic device. There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.).

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

First Glove Blue Nitrile Examination Gloves 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

First Glove Blue Nitrile Examination Gloves Powder Free are equivalent to Class I patient examination gloves bearing the product code LZA (21CFR880.6250). 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 Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, finger textured, ambidextrous with beaded cuff and single use only.

First Glove Blue Nitrile Examination Gloves Powder Free with sizes Extra Small, Small, Medium, Large, Extra Large and Extra Extra Large are included in the submission.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

The performance test data of the non-clinical tests meet the following standards:
ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
ANSI AAMI ISO 10993-10:2010/(R)2014 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
ANSI AAMI ISO 10993-5:2009/(R)2014 Biological Evaluation of Medical Devices - Part 5, Tests for In Vitro Cytotoxicity.
ANSI AAMI ISO 10993-11:2017 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity.

Key results from non-clinical testing included:

Length: XS: 247.00 mm, S: 247.23 mm, M: 252.54 mm, L: 250.92 mm, XL: 245.54 mm, XXL: 251.00 mm (all meeting or exceeding minimums)
Width: XS: 74.31 mm, S: 85.08 mm, M: 94.85 mm, L: 105.38 mm, XL: 110.77 mm, XXL: 121.31 mm (all within +/-10 mm range)
Thickness: Palm Min 0.05 mm, Finger Min 0.05 mm (all sizes). Size Palm(Avg)mm Finger(Avg)mm: XS 0.07 0.10, S 0.06 0.10, M 0.07 0.10, L 0.06 0.10, XL 0.07 0.11, XXL 0.07 0.10.
Tensile strength (Before Ageing): XS 35.25 MPa, S 29.47 MPa, M 27.72 MPa, L 30.12 MPa, XL 36.26 MPa, XXL 33.60 MPa (all ≥14 MPa).
Tensile strength (After Ageing): XS 35.75 MPa, S 30.02 MPa, M 28.75 MPa, L 29.55 MPa, XL 31.20 MPa, XXL 35.66 MPa (all ≥14 MPa).
Ultimate Elongation (Before Ageing): XS 537 %, S 525 %, M 525 %, L 523 %, XL 528 %, XXL 533 % (all ≥500 %).
Ultimate Elongation (After Ageing): XS 493 %, S 478 %, M 516 %, L 495 %, XL 485 %, XXL 502 % (all ≥400 %).
Freedom from Holes: Gloves Passes AQL 2.5.
Powder Free Residue: XS: 0.04 mg/glove, S: 0.28 mg/glove, M: 0.04 mg/glove, L: 0.04 mg/glove, XL: 0.26 mg/glove, XXL: 0.48 mg/glove (all ≤ 2 mg/glove).
Biocompatibility: Test article considered a non-irritant, not considered to be a contact sensitizer. Cytotoxic at extract concentrations of 100%, 66.7%, 44.4%, 29.6% and 19.8% and did not produce a cytotoxic effect at 13.2%. No acute systemic toxic induced.

Clinical data is not needed for gloves.

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.

K202384

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.

K211351

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 30, 2023

First Glove Sdn. Bhd. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. Ste 114 Aurora, Illinois 60504

Re: K230958

Trade/Device Name: First Glove Blue Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: March 13, 2023 Received: April 4, 2023

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.

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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 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 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.

Bifeng Qian -S

Bifeng Oian, M.D., 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

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Indications for Use

510(k) Number (if known) K230958

Device Name

First Glove Blue Nitrile Examination Gloves Powder Free

Indications for Use (Describe)

First Glove Blue Nitrile Examination Gloves 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)
☐ Prescription Use (Part 21 CFR 801 Subpart D)	☑ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY K230958 AS REQUIRED BY: 21CFR§807.92

A. APPLICANT INFORMATION

510(K) Owner's Name	FIRST GLOVE SDN. BHD.
Address	Unit 23-2, Level 23, Binjai 8, No. 2, Lorong Binjai,
Kuala Lumpur, Wilayah Persekutuan, Malaysia

|
| Phone | +60 12-389 1644, +603 2181 8201 |
| Fax | +603 2181 7201 |
| E-mail | dean@firstglove.com, |
| Contact Person | Mr. Dean Segal |
| Designation | President |
| Contact Number | +60 12-389 1644 |
| Contact Email | dean@firstglove.com |
| Date Submitted | 13 March 2023 |

B. DEVICE IDENTIFICATION

| Name of the device | First Glove Blue Nitrile Examination Gloves Powder
Free |
|-----------------------------------|------------------------------------------------------------|
| Product proprietary or trade name | First Glove |
| Common or usual name | Blue Nitrile Examination Gloves Powder Free |
| Classification name | Non-powdered patient examination glove |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

C. PREDICATE DEVICE

Predicate Device	Palm Care Blue Nitrile Examination Gloves Powder free
510(k) Number	K202384
Regulatory Class	Class 1
Product code	LZA

Reference Device	Nitrile Patient Examination Gloves
510(k) Number	K211351
Regulatory Class	Class 1
Product code	LZA

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510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92

D. DESCRIPTION OF THE DEVICE:

First Glove Blue Nitrile Examination Gloves Powder Free are equivalent to Class I patient examination gloves bearing the product code LZA (21CFR880.6250). 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 Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, finger textured, ambidextrous with beaded cuff and single use only.

First Glove Blue Nitrile Examination Gloves Powder Free with sizes Extra Small, Small, Medium, Large, Extra Large and Extra Extra Large are included in the submission.

E. INDICATIONS FOR USE OF THE DEVICE:

First Glove Blue Nitrile Examination Gloves 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.

F.SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE			COMPARISON
		PREDICATE	REFERENCE	SUBJECT
510(k) Number	---	K202384	K211351	K230958	---
Name of device	---	Palm Care Blue
Nitrile
Examination
Gloves Powder
free	Nitrile Patient
Examination
Gloves	First Glove Blue
Nitrile Examination
Gloves Powder
Free	---
Product Code	---	LZA	LZA	LZA	Same
Indications for Use	---	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.	The Nitrile
Patient
Examination
Gloves are non-
sterile disposable
devices intended
for medical purposes
that are worn on
the examiner's
hands or finger to
prevent
contamination
between patient
and examiner.	First Glove Blue
Nitrile
Examination
Gloves 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.	Same
Regulation Number	---	21 CFR 880.6250	21 CFR 880.6250	21 CFR 880.6250	Same
Material	ASTM
D6319-19	Nitrile (NBR)	Nitrile	Nitrile (NBR)	Same
Color	---	Blue	Blue	Blue	Same
Texture	---	Finger Texture	---	Finger Texture	Same as
predicate
device

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CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE			COMPARISON
		PREDICATE	REFERENCE	SUBJECT
510(k) Number	---	K202384	K211351	K230958	---
Size	ASTM
D6319-19	Extra Small, Small, Medium, Large, Extra Large	XS, S, M, L, XL, XXL	XS, S, M, L, XL, XXL	Same as reference device
Design Feature	---	Ambidextrous	Ambidextrous	Ambidextrous	Same
Single Use	Medical Glove Guidance Manual-Labeling	Single Use	Single Use	Single Use	Same
Sterile/non sterile	---	Nonsterile	Non-Sterile	Nonsterile	Same
Powder/Powder free	---	Powder free	Powder free	Powder free	Same
Dimensions- Length	ASTM
D6319-19	Length Min 230 mm
(for medium size)	Length (mm):
XS/S:≥220;
M/L/XL/XXL:
≥230	Length (mm):
XS/S:≥220;
M/L/XL/XXL:
≥230
Size Average XS 247.00 S 247.23 M 252.54 L 250.92 XL 245.54 XXL 251.00							Same as reference device
Dimensions- Width	ASTM
D6319-19	Width Min 95+/-
10mm
(for medium size)	Width (mm):
XS:70±10;
S:80±10;
M:95±10;
L:110±10;
XL:120±10;
XXL:130±10	Width (mm):
XS:70±10;
S:80±10;
M:95±10;
L:110±10;
XL:120±10;
XXL:130±10
Size Average XS 74.31 S 85.08 M 94.85 L 105.38 XL 110.77 XXL 121.31							Same as reference device
Physical Properties-
Tensile Strength	ASTM
D6319-19	Before Ageing
Tensile Strength
Min 14 MPa	Before Ageing
Tensile
Strength
14MPa, min	Before Ageing
Tensile Strength
Min 14 MPa
Size Average XS 35.25 S 29.47 M 27.72 L 30.12 XL 36.26						Same

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CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
		PREDICATE	REFERENCE	SUBJECT
510(k) Number		K202384	K211351	K230958
Physical Properties-
Tensile Strength	ASTM
D6319-19	After Ageing
Tensile Strength
Min14 MPa	After Ageing
Tensile
Strength
14MPa, min	After Ageing
Tensile Strength
Min 14 MPa
Size Average XS 35.75 S 30.02 M 28.75 L 29.55 XL 31.20 XXL 35.66					Same
Physical Properties-
Ultimate Elongation	ASTM
D6319-19	Before Ageing
Ultimate
Elongation
Min 500%	Before Ageing
Ultimate
Elongation
500% min	Before Ageing
Ultimate Elongation
Min 500%
Size Average XS 537 S 525 M 525 L 523 XL 528 XXL 533					Same
Physical Properties-
Ultimate Elongation	ASTM
D6319-19	After Ageing
Ultimate
Elongation
Min 400%	After Ageing
Ultimate
Elongation
400% min	After Ageing
Ultimate Elongation
Min 400%
Size Average XS 493 S 478 M 516 L 495 XL 485 XXL 502					Same
Thickness	ASTM
D6319-19	Palm Min
0.05mm
Finger Min
0.05mm	Thickness
(mm):
Palm: ≥0.05
Finger: ≥0.05	Palm Min 0.05 mm
Finger Min 0.05mm
Size Palm
(Avg)
mm Finger
(Avg)
mm XS 0.07 0.10 S 0.06 0.10 M 0.07 0.10 L 0.06 0.10 XL 0.07 0.11 XXL 0.07 0.10						Same
Powder Free Residue	ASTM
D6319-19	≤2 mg/glove	Meet the
requirements
of ASTM
D6124