Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a standard medical examination glove and focuses on physical properties and compliance with ASTM standards. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.

Therapeutic

No
The device is a glove intended to prevent contamination, not to treat or diagnose a medical condition.

Diagnostic

No
The device is described as a "powder-free patient examination glove," which is intended to "prevent contamination between patient and examiner." Its function is protective and preventive, not diagnostic (i.e., it does not aim to identify or determine a disease or condition).

SaMD (Software as a Medical Device)

No

The device is a physical product (gloves) and the description focuses on material properties and physical testing, not software functionality.

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 for protection, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
Device Description: The description focuses on physical properties, materials (nitrile), and standards compliance (ASTM D6319). There is no mention of analyzing biological samples or providing diagnostic information.
Performance Studies: The performance studies described evaluate physical characteristics like dimensions, tensile strength, freedom from holes, and powder content. These are relevant to the barrier function of a glove, not the analytical performance of a diagnostic test.
Lack of IVD Indicators: There is no mention of analyzing specimens, detecting analytes, or providing diagnostic results.

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

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A powder-free 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 Powder Free Nitrile Examination Gloves are non sterile, single use, and disposable. These gloves are available in Blue, Green, and Black colors. This device is to protect the examiner and prevent contamination between patient and the examiner when properly worn. The sizes of the gloves are Small, Medium, Large and X-Large. Non Sterile Nitrile Powder Free Examination Gloves meet all current specifications listed under ASTM Specifications D6319.

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 (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 device met ASTM D6319 criteria for dimensions (overall length, width, palm thickness, finger thickness), physical properties (tensile strength before and after aging, ultimate elongation before and after aging), and freedom from holes/watertight integrity (Pinhole AQL). It also met ASTM D6124 criteria for powder-free/residual powder content.

Key Results:

Overall Length (Small, Medium, Large, X-Large): Passed for all colors (Blue, Green, Black), meeting or exceeding the 220-230 mm minimum requirement.
Width (Small, Medium, Large, X-Large): Passed for all colors, falling within the specified ASTM D6319 ranges.
Palm Thickness (Small, Medium, Large, X-Large): Passed for all colors, meeting or exceeding the 0.05 mm minimum.
Finger Thickness (Small, Medium, Large, X-Large): Passed for all colors, meeting or exceeding the 0.05 mm minimum.
Tensile Strength (Before Aging) (Small, Medium, Large, X-Large): Passed for all colors, meeting or exceeding the 14 MPa minimum.
Tensile Strength (After Aging) (Small, Medium, Large, X-Large): Passed for all colors, meeting or exceeding the 14 MPa minimum.
Ultimate Elongation (Before Aging) (Small, Medium, Large, X-Large): Passed for all colors (except X-large black gloves were 460-540%, 500% minimum), meeting or exceeding the 500% minimum.
Ultimate Elongation (After Aging) (Small, Medium, Large, X-Large): Passed for all colors, meeting or exceeding the 400% minimum.
Freedom from Holes (Pinhole Inspection) (Small, Medium, Large, X-Large): Passed for all glove sizes and colors based on AQL=2.5.
Powder Free/Powder Content (Small, Medium, Large, X-Large): Passed for all colors, not exceeding 2 mg per glove.

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

DIMENSIONS:

Overall Length:
- Small: 220 mm minimum
- Medium: 230 mm minimum
- Large: 230 mm minimum
- X large: 230 mm minimum
Width:
- Small: 80 +/- 10 mm
- Medium: 95 +/- 10 mm
- Large: 110 +/- 10 mm
- X large: 120 +/- 10 mm
Palm Thickness: 0.05 mm minimum
Finger thickness: 0.05 mm minimum

PHYSICAL PROPERTIES:

Tensile Strength (before aging): 14 MPa, Minimum
Tensile Strength (after aging): 14 MPa, Minimum
Ultimate Elongation (before aging): 500 % Minimum
Ultimate Elongation (after aging): 400 % Minimum

FREEDOM FROM HOLES/Watertight:

Per ASTM D5151-06 (2011)
Pinhole AQL: Inspection Level G-1; AQL=2.5

POWDER FREE/Residual Powder:

Residue limit of 2.0 mg/glove

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.

K143289

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

Not Found

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

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

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

December 13, 2021

Mexpo International Inc. Tim Thai Official Correspondent 2828 Faber Street Union City, California 94587

Re: K210388

Trade/Device Name: Non Sterile Nitrile Powder Free Examination Gloves - Blue, Green and Black color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 10, 2021 Received: November 12, 2021

Dear Tim Thai:

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 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 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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Indications for Use

510(k) Number (if known) K210388

Device Name

NON STERILE NITRILE POWDER FREE EXAMINATION GLOVES - BLUE, GREEN AND BLACK COLOR

Indications for Use (Describe)

A powder-free patient examination glove is a disposable device intended for medical purposes that is wom 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)

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

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510K SUMMARY

Date of Summary Prepared: November 9, 2021

510K Number: K210388

Applicant : MEXPO INTERNATIONAL INC. Address : 2828 Faber Street, Union City, CA 94587, U.S.A. Tel : 510 — 489 6800 Fax : 510-489 3111 E-mails : : mexpoglove@aol.com and acct@mexpo-glove.com

Official Correspondence: Tim Thai (President)

1. Device Name: Non Sterile Nitrile Powder Free Examination Gloves Blue, Green And Black color.

3. Regulatory Information

Classification Name	: Nitrile Powder Free Examination Gloves
Classification	: Class I
Product Code	: LZA
Regulation Number	: 21 CFR 880.6250

4. Predicate Device

510K Number	: K143289- YTY Industry (Manjung) Sdn. Bhd.
Device Name	: Non Sterile, Powder Free Nitrile Examination Gloves -
Orange, Green, Blue and Violet Color.

5. Intended Use

A powder-free 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.

6. Description

The Powder Free Nitrile Examination Gloves are non sterile, single use, and disposable. These gloves are available in Blue, Green, and Black colors. This device is to protect the examiner and prevent contamination between patient and the examiner when properly worn. The sizes of the gloves are Small, Medium, Large and X-Large. Non Sterile Nitrile Powder Free Examination Gloves meet all current specifications listed under ASTM Specifications D6319.

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Summary of Comparison and Technological Characteristic
Table 1 - General Comparison
	SUBJECT DEVICE:
K210388	PREDICATE DEVICE:
K143289	Comparison
Company Name	Mexpo International Inc.	YTY INDUSTRY
(MANJUNG) SDN. BHD
Product Name	Non Sterile, Powder Free
Nitrile Examination
Gloves-BLUE, GREEN AND
BLACK	Non Sterile, Powder Free
Nitrile Examination
Gloves-Orange, Green,
Blue and Violet Color
Available Colors	Blue, Green and Black	Blue, Green and Others	Similar
Available Sizes	Small, Medium, Large and
X-Large	Not specified but data
provided on Medium	Similar
Indications for Use	A powder free 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 patient examination
gloves is a disposable
device intended for
medical purpose that is
worn on the examiner's
hand or finger to prevent
contamination between
patient and examiner.	Similar. The subject
device includes language
to clarify that it is
powder free as
recommended in the
FDA's Glove Guidance
Document
MATERIALS	Carboxylated Butadiene
Acrylonitrile as base
material	Carboxylated Butadiene
Acrylonitrile as base
material	Same
DIMENSIONS	Meets ASTM D6319
Criteria	Meets ASTM D6319
Criteria	Same
PHYSICAL
PROPERTIES	Meets ASTM D6319
Criteria	Meets ASTM D6319
Criteria	Same
FREEDOM FROM
HOLES/Watertight	Meets ASTM
D6319/ASTM D5151
Criteria	Meets ASTM D5151
Criteria	Same
POWDER
FREE/Residual Powder	Meets ASTM D6124
Criteria	Meets ASTM D6124
Criteria	Same
BIOCOMPATABILITY	Per ISO 10993-10: Non-
irritant (Response
Category is Negligible)
and Non-sensitizer (No
sensitization)

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Table 2 Specifications and Performance Test Results Comparison

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Table 3 Summary of Device Specifications and Performance Results

| | ASTM D6319
Requirement | BLUE Gloves | GREEN Gloves | BLACK Gloves |
|------------------|---------------------------|---------------------|---------------------|---------------------|
| DIMENSIONS | | | | |
| Overall Length | | | | |
| -Small | 220 mm minimum | Pass (242-253 mm) | Pass (237-243 mm) | Pass (239-248 mm) |
| -Medium | 230 mm minimum | Pass (240-246 mm) | Pass (240-247 mm) | Pass (244-251 mm) |
| -Large | 230 mm minimum | Pass (245-255 mm) | Pass (240-247 mm) | Pass (243-251 mm) |
| -X large | 230 mm minimum | Pass (243-253 mm) | Pass (240-250 mm) | Pass (241-277 mm) |
| Width | | | | |
| -Small | $80 \pm 10$ mm | Pass (85-87 mm) | Pass (86-88 mm) | Pass (85-86 mm) |
| -Medium | $95 \pm 10$ mm | Pass (95-98 mm) | Pass (95-96 mm) | Pass (95-97 mm) |
| -Large | $110 \pm 10$ mm | Pass (106-109 mm) | Pass (106-106 mm) | Pass (105-106 mm) |
| -X large | $120 \pm 10$ mm | Pass (113-115 mm) | Pass (114-116 mm) | Pass (115-115 mm) |
| Palm Thickness | | | | |
| -Small | 0.05 mm
minimum | Pass (0.06-0.07 mm) | Pass (0.12-0.14 mm) | Pass (0.07-0.08 mm) |
| -Medium | 0.05 mm
minimum | Pass (0.06-0.06 mm) | Pass (0.13-0.13 mm) | Pass (0.07-0.07 mm) |
| -Large | 0.05 mm
minimum | Pass (0.05-0.07 mm) | Pass (0.11-0.13 mm) | Pass (0.07-0.07 mm) |
| -X large | 0.05 mm
minimum | Pass (0.06-0.06 mm) | Pass (0.12-0.13 mm) | Pass (0.06-0.07 mm) |
| Finger thickness | | | | |
| -Small | 0.05 mm
minimum | Pass (0.09-0.11 mm) | Pass (0.15-0.17 mm) | Pass (0.11-0.13 mm) |
| -Medium | 0.05 mm
minimum | Pass (0.09-0.10 mm) | Pass (0.15-0.18 mm) | Pass (0.11-0.13 mm) |
| -Large | 0.05 mm
minimum | Pass (0.10-0.11 mm) | Pass (0.15-0.16 mm) | Pass (0.11-0.13 mm) |
| -X large | 0.05 mm
minimum | Pass (0.10-0.11 mm) | Pass (0.15-0.16 mm) | Pass (0.11-0.14 mm) |

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| | ASTM D6319
Requirement | BLUE Gloves |---------------------|--------------- | PHYSICAL PROPERTIES | | | Tensile | -Small | 14 MPa minimum | -Medium | 14 MPa minimum | -Large | 14 MPa minimum | -X large | 14 MPa minimum | | Tensile | -Small | 14 MPa minimum | -Medium | 14 MPa minimum | -Large | 14 MPa minimum | -X large | 14 MPa minimum | | Ultimate | -Small | 500% minimum | -Medium | 500% minimum | -Large | 500% minimum | -X large | 500% minimum | | Ultimate | -Small | 400% minimum | -Medium | 400% minimum | -Large | 400% minimum | -X large | 400% minimum | GREEN Gloves | BLACK Gloves |
---------------------|----------------------|----------------------|----------------------|
| | | |
Strength (Before Aging) | | | |
| Pass (25.2-31.9 MPa) | Pass (24.1-34.1 MPa) | Pass (33.5-41.2 MPa) |
| Pass (25.9-32.0 MPa) | Pass (25.9-32.0 MPa) | Pass (34.3-46.5 MPa) |
| Pass (23.9-34.3 MPa) | Pass (21.2-28.8 MPa) | Pass (31.6-42.2 MPa) |
| Pass (28.2-39.2 MPa) | Pass (19.6-29.9 MPa) | Pass (25.2-43.5 MPa) |
Strength (After Aging) | | | |
| Pass (25.6-34.9 MPa) | Pass (24.4-38.1 MPa) | Pass (25.7-43.5 MPa) |
| Pass (25.4-34.0 MPa) | Pass (24.8-32.3 MPa) | Pass (34.7-45.8 MPa) |
| Pass (24.0-37.4 MPa) | Pass (20.7-33.9 MPa) | Pass (35.1-43.0 MPa) |
| Pass (33.2-40.2 MPa) | Pass (21.6-32.1 MPa) | Pass (24.7-44.8 MPa) |
Elongation (Before Aging) | | | |
| Pass (500-540%) | Pass (500-580%) | Pass (540-600%) |
| Pass (500-540%) | Pass (500-560%) | Pass (520-600%) |
| Pass (500-560%) | Pass (500-580%) | Pass (520-600%) |
| Pass (500-560%) | Pass (540-580%) | Pass (460-540%) |
Elongation (After Aging) | | | |
| Pass (480-520%) | Pass (460-540%) | Pass (540-580%) |
| Pass (480-520%) | Pass (460-540%) | Pass (520-600%) |
| Pass (480-520%) | Pass (480-560%) | Pass (520-560%) |
| Pass (480-520%) | Pass (500-560%) | Pass (440-520%) |

	ASTM D6319 Requirement	BLUE Gloves	GREEN Gloves	BLACK Gloves
FREEDOM FROM HOLES (Pinhole Inspection)
-Small	AQL=2.5; Accept on 10 (n=200)	Pass (Found=1)	Pass (Found=0)	Pass (Found=2)
-Medium	AQL=2.5; Accept on 7 (n=200)	Pass (Found=0)	Pass (Found=0)	Pass (Found=0)
-Large	AQL=2.5; Accept on 10 (n=200)	Pass (Found=1)	Pass (Found=1)	Pass (Found=0)
-X Large	AQL=2.5; Accept on 10 (n=200)	Pass (Found=0)	Pass (Found=6)	Pass (Found=1)
	ASTM D6124
Requirement	BLUE Gloves	GREEN Gloves	BLACK Gloves
POWDER FREE/Powder Content
-Small	does not exceed 2
mg per glove	Pass (Average: 0.36
mg per glove)	Pass (Average: 0.18
mg per glove)	Pass (Average: 0.04
mg per glove)
-Medium	Does not exceed
2 mg per glove	Pass (Average: 0.70
mg per glove)	Pass (Average: 0.10
mg per glove)	Pass (Average: 0.06
mg per glove)
-Large	Does not exceed
2 mg per glove	Pass (Average: 0.30
mg per glove)	Pass (Average: 0.16
mg per glove)	Pass (Average: 0.04
mg per glove)
-X Large	Does not exceed
2 mg per glove	Pass (Average: 1.02
mg per glove)	Pass (Average: 0.24
mg per glove)	Pass (Average: 0.10
mg per glove)

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7. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210388, MEXPO NON STERILE NITRILE POWDER FREE EXAMINATION GLOVES – BLUE, GREEN AND BLACK, is as safe, as effective, and performs as well as or better than the legally marketed predicate device Non Sterile, Powder Free Nitrile Examination Gloves-Orange, Green, Blue and Violet Color in K143289.