Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and performance of a patient examination glove, with no mention of AI or ML technology.

Therapeutic

No.
The 'Intended Use' states that the device is a glove for preventing contamination, which is a barrier function, not a therapeutic one.

Diagnostic

No

Explanation: The device is a patient examination glove, intended for preventing contamination between a patient and examiner, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove, which is a hardware medical 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 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 protection, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment.
Device Description: The description focuses on the physical properties and materials of the glove, not on any components or processes related to analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any diagnostic procedures.
Regulatory Classification: Patient examination gloves are typically classified under different regulatory categories than IVDs (e.g., Class I or II medical devices for general use). The mention of FDA 21 CFR 880.6250 further supports this, as this regulation pertains to patient examination gloves, not IVDs.

In summary, the device is a medical device used for barrier protection, not for in vitro diagnostic testing.

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

Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.

The powder free nitrile examination qlove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

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)

The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.

Physical Properties:

Test Method: ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension)
Purpose of Testing: To evaluate the tensile (tension) properties of glove.
Acceptance Criteria (Before aging): Tensile strength Min 14.0 MPa, Ultimate elongation Min 500%
Acceptance Criteria (After aging): Tensile strength Min 14.0 MPa, Ultimate elongation Min 400%
Results (Before aging): Tensile strength 32.35Mpa, Ultimate elongation 568%
Results (After aging): Tensile strength 36.10Mpa, Ultimate elongation 551%
Status: Pass

Dimension:

Test Method: ASTM D3767 Standard Practice for Rubber—Measurement of Dimensions
Purpose of Testing: To measure the length, width and thickness of glove
Acceptance Criteria (for all sizes): Length Min 240 mm, Thickness Finger – min 0.05mm, Palm - min 0.05mm
- X-Small: Width 70 ± 10 mm
- Small: Width 80 ± 10 mm
- Medium: Width 95 ± 10 mm
- Large: Width 110 ± 10 mm
- X-Large: Width 120 ± 10 mm
Results: All sizes passed.
- X-Small: Length 250 mm, Width 78.0 mm, Thickness 0.10 mm (Finger), 0.07 mm (Palm)
- Small: Length 249 mm, Width 87.0 mm, Thickness 0.10 mm (Finger), 0.07 mm (Palm)
- Medium: Length 249 mm, Width 98.0 mm, Thickness 0.10 mm (Finger), 0.07 mm (Palm)
- Large: Length 248 mm, Width 107 mm, Thickness 0.10 mm (Finger), 0.07 mm (Palm)
- X-Large: Length 250 mm, Width 117 mm, Thickness 0.10 mm (Finger), 0.07 mm (Palm)
Status: Pass

Watertight:

Test Method: ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
Purpose of Testing: To detect holes that leak water and thereby compromise the usefulness of the glove.
Acceptance Criteria: Sample size: 500 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10
Results: The batch size for this sampling is 150,001 to 500,000. Hence, according to the single sampling plan GI, the sample to be drawn is under code M equivalent to 315 pieces with accept 10 and reject 11 to be accepted under AQL 1.5. During the test, 1 piece was found with leaks. Hence it falls within the acceptance criteria.
Status: Pass

Residual Powder:

Test Method: ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
Purpose of Testing: To determine the amount of residual powder and non-powder solids found on gloves.
Acceptance Criteria: Less than 2 mg per glove
Results: Sample size: 5 pcs, Requirement:

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 & 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 7, 2021

Onetexx SDN BHD % Michael Woude U.S. Agent Emergo Global Representation 2500 Bee Cave Road. Building 1 Suite 300 Austin, Texas 78746

Re: K210366

Trade/Device Name: Blue Nitrile Powder Free Patient Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 3, 2021 Received: February 8, 2021

Dear Michael Woude:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

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 (OS) 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,

For Ryan Ortega, Ph. D Acting Assistant Director DHT4A: Division of General 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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Indications for Use

510(k) Number (if known) K210366

Device Name BLUE NITRILE POWDER FREE PATIENT EXAMINATION GLOVE, NON STERILE

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)

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

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510(k) No: K210366

1.0 Submitter:

Name:	Freddy Low
Address:	Onetexx Sdn Bhd
No: 73-86, Jalan Logam 5, Perindustrian Kamunting 3,
Kamunting Raya Industrial Estate, 34600 Kamunting, Perak
Darul Ridzuan, Malaysia
Phone No.:	+60 5 8070 666
Fax No.:	+60 5 8070 666

Date of Summary Prepared: 3rd February 2021

2.0 Identification of the subject device:

: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile Trade Name Common Name : Patient Examination Gloves Classification Name : Patient Examination Gloves Device Classification : 1 Regulation Number : 21 CFR 880.6250 Product Code : LZA.

3.0 Predicate Device:

K192333

Blue Nitrile Examination Gloves Powder Free Company: JR Engineering & Medical Technologies (M) SDN. BHD.

4.0 Description of The Device:

Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.

The powder free nitrile examination qlove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

5.0 Indication for use:

A patient examination glove is a disposable device made of synthetic rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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510(k) No: K210366

Summary of the Technological Characteristics of the Device: 6.0

The Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1.

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510(k) No: K210366

Table 1

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON
ANALYSIS |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | | PREDICATE
BLUE | CURRENT
BLUE | |
| 510(k) Number | - | K192333 | | |
| Manufacturer(s) | - | JR Engineering & Medical
Technologies (M) SDN. BHD. | Onetexx Sdn Bhd | Same |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger texture | Finger Texture | Same |
| Physical Properties
Before Aging
Tensile Strength:
Ultimate Elongation: | ASTM D6319 | 25.6Mpa
868% | 32.35Mpa
568% | Different but
within the ASTM
standard |
| After Aging
Tensile Strength:
Ultimate Elongation: | ASTM D6319 | 22.0Mpa
828% | 36.10Mpa
551% | Different but
within the ASTM
standard |
| Thickness:

Finger
Palm | ASTM D6319 | 0.22mm
0.20mm | 0.10mm
0.07mm | Different but
within the ASTM
standard |
| Powder Free | ASTM D6124 | 0.21 mg/glove | 0.24 mg/glove | Different but
within the ASTM
standard |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE
BLUE | CURRENT
BLUE | |
| Biocompatibility | Primary Skin Irritation
ISO 10993-10:2010
(E) & Consumer
Product Safety
Commission Title 16.
Chapter II, Part 1500 | Under the condition of study not an irritant | The test material did not cause an irritant response. The Primary Irritant Response Category is deemed 'Negligible' | Similar |
| | Dermal Sensitization-
ISO 10993-10: 2010
(E) & Consumer
Product Safety
Commission, Title 16,
Chapter II, Part
1500.3 (c) (4) | Under the conditions of the study not a sensitizer | The test material did not produce a skin sensitization effect in the guinea pigs. | Similar |
| | Cytotoxicity - MEM
Elution, ISO 10993-5:
2009 (E) | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. | The test material demonstrated a cytotoxic effect under the condition of this study. Additional test i.e. Acute Systemic Toxicity was tested. | Similar |

6

7

		DEVICE PERFORMANCE
CHARACTERISTICS	STANDARDS	PREDICATE	CURRENT	COMPARISON
ANALYSIS
		BLUE	BLUE
Biocompatibility	Acute Systemic
Toxicity, ISO 10993-
11:2017 (E)	Under the conditions of study,
the device extracts do not pose
a systemic toxicity concern	The test item did not induce
any systemic toxicity.	Similar
Watertight (1000ml)	ASTM D5151:2019	Gloves passes AQL 1.5	Gloves passed AQL 1.5	Same
Intended use		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.	A patient examination glove is a
disposable device made of
synthetic rubber latex intended
for medical purposes that is
worn on the examiner's hand or
finger to prevent contamination
between patient and examiner.	Same
Size	Medical Glove
Guidance Manual –
Labeling	Extra Small
Small
Medium
Large
Extra Large	Extra Small
Small
Medium
Large
Extra Large	Same
Single use	Medical Glove
Guidance Manual –
Labeling	Single Use	Single Use	Same

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510(k) No: K210366

There are no significant differences between the two products and are identical in terms of intended use, materials design and biocompatibility test, however the performance data for proposed product is different on the physical properties (higher on Tensile Strength but lower on the elongation compared to predicate device) and glove thickness (lower than the predicate device) but well within the ASTM D 6139 standard.

7.0 Summary of Non-Clinical Testing

The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.

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| Test

Method	Standard	Purpose of Testing	Acceptance Criteria
			Before
aging	After
aging	Before
aging	After
aging
Physical
Properties	ASTM D412
(Standard Test
Method for
Vulcanized Rubber
and Thermoplastic
Elastomers-Tension)	To evaluate the
tensile (tension)
properties of glove.	Tensile
strength	Min 14.0
MPa	Min 14.0
MPa	32.35Mpa	36.10Mpa	Pass
			Ultimate
elongation	Min
500%	Min
400%	568%	551%	Pass

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| Test
Method | Standard | Purpose of
Testing | Glove
Size | Acceptance Criteria | Results | Status |
|----------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------|---------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|--------|
| Dimension | ASTM D3767
Standard
Practice for
Rubber—
Measurement
of Dimensions | To measure the
length, width and
thickness of
glove | X-Small | Length
Min 240 mm
Width
$70 \pm 10$ mm
Thickness
Finger – min 0.05mm
Palm - min 0.05mm | Length
250 mm
Width
78.0 mm
Thickness
0.10 mm
0.07 mm | Pass |
| | | | Small | Length
Min 240 mm
Width
$80 \pm 10$ mm
Thickness
Finger – min 0.05mm
Palm - min 0.05mm | Length
249 mm
Width
87.0 mm
Thickness
0.10 mm
0.07 mm | Pass |
| | | | Medium | Length
Min 240 mm
Width
$95 \pm 10$ mm
Thickness
Finger – min 0.05mm
Palm - min 0.05mm | Length
249 mm
Width
98.0 mm
Thickness
0.10 mm
0.07 mm | Pass |
| | | | Large | Length
Min 240 mm
Width
$110 \pm 10$ mm | Length
248 mm
Width
107 mm | Pass |

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| | | | | Thickness | Finger – min 0.05mm
Palm - min 0.05mm | Thickness | 0.10 mm
0.07 mm | Pass |
|--|--|---------|-----------|------------------------------------------|------------------------------------------|--------------------|--------------------|------|
| | | X-Large | Length | Min 240 mm | Length | 250 mm | Pass | |
| | | | Width | $120 \pm 10$ mm | Width | 117 mm | Pass | |
| | | | Thickness | Finger – min 0.05mm
Palm - min 0.05mm | Thickness | 0.10 mm
0.07 mm | Pass | |

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| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
|----------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Watertight | ASTM D5151
(Standard Test
Method for
Detection of Holes
in Medical Gloves) | To detect holes
that leak water
and thereby
compromise the
usefulness of the
glove. | Sample size: 500 pcs
Inspection level: G1
AQL: 1.5, Acceptance No. 10 | The batch size for this
sampling is 150,001 to
500,000. Hence,
according to the single
sampling plan GI, the
sample to be drawn is
under code M
equivalent to 315
pieces with accept 10
and reject 11 to be
accepted under AQL
1.5. During the test, 1
piece was found with
leaks. Hence it falls
within the acceptance
criteria. | Pass |

| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
|--------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------------------------------------|--------|
| Residual
Powder | ASTM D6124
(Standard Test
Method for Residual
Powder on Medical
Gloves) | To determine the
amount of
residual powder
and non-powder
solids found on
gloves. | Less than 2 mg per glove | Sample size : 5 pcs
Requirement :