Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance data focus on the physical properties and barrier function of latex gloves, with no mention of AI or ML.

Therapeutic

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

Diagnostic

No
The device is described as an examination glove intended to prevent contamination, not to diagnose conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product made of natural rubber latex (gloves) and describes physical performance testing.

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 "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
Device Description: The description focuses on the physical properties and barrier function of the glove. There is no mention of analyzing biological samples or providing diagnostic information.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting analytes or markers
- Providing diagnostic or monitoring information
- Reagents or assays

The device is a medical device, specifically a Class I device (based on the predicate device K173053 which is a Class I glove), but it falls under the category of a barrier device for infection control, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Examination gloves-Type A (Latex gloves) 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

LYY

Device Description

The proposed device, The Examination gloves-Type A ( Latex gloves ) 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 proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is provided non-sterile and the shelf life is 5 years.

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)

Test item: Dimension

Test standard: ASTM D3578-19
Acceptance Criteria: Length: Min 230 mm for all sizes; Width: Small: 80 ± 10 mm, Medium: 95±10mm, Large: 111± 10 mm; Thickness: Palm: 0.08 mm min, Finger: 0.08 mm min
Test result: Length: S:240-244mm, M:241-245mm, L:242-245mm; Width: S: 84-86mm, M:96-98mm, L:105-108mm; Thickness: Palm:0.11-0.13mm, Finger: 0.13-014mm
Conclusion: Pass

Test item: Physical Properties- Tensile strength

Test standard: ASTM D3578-19
Acceptance Criteria: Before Ageing Tensile Strength: 18Mpa Minimal for all sizes; After Ageing Tensile Strength 14Mpa Minimal for all sizes
Test result: Before Ageing Tensile Strength: 20.6Mpa Min; After Ageing Tensile Strength 18.9Mpa Min
Conclusion: Pass

Test item: Physical Properties- Ultimate Elongation

Test standard: ASTM D3578-19
Acceptance Criteria: Before Ageing Ultimate Elongation: 650% Min for all sizes; After Ageing Ultimate Elongation 500% Min for all sizes
Test result: Before Ageing Ultimate Elongation: 683% Min; After Ageing Ultimate Elongation 623% Min
Conclusion: Pass

Test item: Watertight test

Test standard: ASTM D5151-19
Acceptance Criteria: Sample size: 200 pcs; Inspection level : GI; AQL 1.5; Acceptance Number 7; Rejection Number 8
Test result: Sample size: 200 pcs; Inspection level : GI; AQL 1.5; Result:0
Conclusion: Pass

Test item: Residual powder

Test standard: ASTM D6124-06
Acceptance Criteria: 2 mg per glove or less
Test result: 0.02mg per glove
Conclusion: Pass

Test item: Protein content

Test standard: ASTM D5712- 15
Acceptance Criteria: 200 µg/dm² Max for all sizes
Test result: 75ug/g
Conclusion: Pass

Test item: Skin Sensitization

Test standard: ISO 10993-10
Acceptance Criteria: Under the conditions of the study not a sensitizer
Test result: Non-sensitizing
Conclusion: Pass

Test item: Irritation

Test standard: ISO 10993-10
Acceptance Criteria: Under the condition of study not an irritant
Test result: Non-irritating
Conclusion: Pass

Test item: Systemic toxicity

Test standard: ISO 10993-11:2017
Acceptance Criteria: Under the conditions of study the device extracts do not pose a systemic toxicity concern
Test result: Non-systemic toxicity
Conclusion: Pass

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

Not Found

Predicate Device(s)

K173053

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 14, 2022

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd % Alice Huang RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room 8208, Second Floor, No 1399, Jiangyue Road Minhang District Shanghai. 201114 China

Re: K214017

Trade/Device Name: Examination gloves-Type A(Latex gloves) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: June 14, 2022 Received: June 21, 2022

Dear Alice Huang:

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, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K214017

Device Name

Examination gloves-Type A (Latex gloves)

Indications for Use (Describe)

The Examination gloves-Type A (Latex gloves) 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) Summary K214017

I. SUBMITTER:

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. No. 316 National road. Xinju, Changshan Town. Jinxian County, Nanchang City, Jiangxi Province, China. Contact Person: Jenny Huang TITEL: International Trade Supervisor TEL: +86 17702094798 Email: sales@jxkmjt.com

Submission Correspondent: Alice Huang Email: alice.huang@mind-link.net Tel:+86 15618536177 Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District, Shanghai

Summary prepared: 07/12/2022

II. DEVICE

Name of Device: Examination gloves-Type A(Latex gloves) Regulation Number: 21 CFR 880.6250 Common Name: Latex patient examination glove Classification Name: Nonpowdered patient examination glove Regulatory Class: I Product Code: LYY

III. PREDICATE DEVICE 510(k) Number: K173053 Product Name: Powder Free Latex Examination Glove Manufacture: Professional Latex Sdn Bhd

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IV. DEVICE DESCRIPTION

The proposed device, The Examination gloves-Type A ( Latex gloves ) 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 proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is provided non-sterile and the shelf life is 5 years.

V. INDICATIONS FOR USE

The Examination gloves-Type A(Latex gloves) 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.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| DEVICE | Subject Device
(K214017) | Primary Predicate Device
(K173053) | Comparison |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | The Examination gloves-Type A
(Latex gloves) 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 | Same |
| Classification
Product Code | LYY | LYY | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | Class I | Class I | Same |
| Powdered
or | Powdered free | Powdered free | Same |

The subject device.

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Powdered free
Material	Natural Rubber Latex		Natural Rubber Latex		Same
Color	No colour pigment added.
Natural White		No colour pigment added.
Natural White		Same
Dimensions	Length:
S: 240-244mm
M: 241-245mm
L: 242-245mm
Width:
S: 84-86mm
M: 96-98mm
L: 105-108mm
Palm Thickness: 0.11-0.13mm
Finger Thickness: 0.13-014mm		Length:
Average:242mm
Width:
Average:
S:85mm
M:95mm
L:104mm
Palm Thickness: Average:0.09
Finger Thickness:Average:0.11		Similar
Meeting
requirement
of ASTM
D 3578
Biocompatibility	Non-sensitizing
Non-irritating
Non-systemic toxicity		Non-sensitizing
Non-irritating		Similar
Meeting
requirement
of ISO 1099
Tensile
strength	Before Aging	20.6MPa, min	Before Aging	23.65MPa	Similar
	Stress at 500 %
Elongation	5.1MPa, max	Stress at 500 %
Elongation	3.5MPa	Meeting
requirement
of ASTM
D 3578
	After Aging	18.9MPa, min	After Aging	20.99MPa
Ultimate
Elongation	Before Aging	683%, min	Before Aging	734%
	After Aging	623%,min	After Aging	622%
Freedom from
Holes	Meets ASTM D5151-19		Meets ASTM D5151-19		Same
Protein
Content	Meets ASTM D5712-2015		Meets ASTM D5712-2015		Same
Powdered
residue	Meets ASTM
D6124-06(Reapproved 2017)		Meets ASTM
D6124-06(Reapproved 2017)		Same
Sterility	Non-sterile		Non-sterile		Same
Single Use	YES		YES		Same
Label and
labeling	Meet FDA's Requirement		Meet FDA's Requirement		Same

VII. SUMMARY OF NON-CLINICAL PERFORMANCE TEST DATA

Test item	Test standard	Acceptance Criteria	Test result
Dimension	ASTM
D3578-19	Length:
Min 230 mm for all sizes	Length:
S:240-244mm
M:241-245mm	Pass
		L:242-245mm
	ASTM
D3578-19	Width:
Small: 80 ± 10 mm
Medium: 95±10mm
Large: 111± 10 mm	Width:
S: 84-86mm
M:96-98mm
L:105-108mm	Pass
	ASTM
D3578-19	Thickness:
Palm: 0.08 mm min
Finger: 0.08 mm min	Thickness:
Palm:0.11-0.13mm
Finger: 0.13-014mm	Pass
Physical Properties-
Tensile strength	ASTM
D3578-19	Before Ageing
Tensile Strength: 18Mpa
Minimal for all sizes
After Ageing Tensile
Strength 14Mpa
Minimal for all sizes	Before Ageing
Tensile Strength:
20.6Mpa Min
After Ageing
Tensile Strength
18.9Mpa Min	Pass
Physical Properties-
Ultimate Elongation	ASTM
D3578-19	Before Ageing
Ultimate Elongation:
650% Min for all sizes
After Ageing
Ultimate Elongation
500% Min for all sizes	Before Ageing
Ultimate Elongation:
683% Min
After Ageing
Ultimate Elongation
623% Min	Pass
Watertight test	ASTM
D5151-19	Sample size: 200 pcs
Inspection level : GI
AQL 1.5
Acceptance Number 7
Rejection Number 8	Sample size: 200 pcs
Inspection level : GI
AQL 1.5
Result:0	Pass
Residual powder	ASTM
D6124-06	2 mg per glove or less	0.02mg per glove	Pass
Protein content	ASTM D5712

15 | 200 µg/dm² Max for all
sizes | 75ug/g | Pass |
| Skin Sensitization | ISO 10993-10 | Under the conditions
of the study not a
sensitizer | Non-sensitizing | Pass |
| Irritation | ISO 10993-10 | Under the condition of
study not an irritant | Non-irritating | Pass |
| Systemic toxicity | ISO 10993-
11:2017 | Under the conditions of
study the device extracts
do not pose a systemic
toxicity concern | Non-systemic
toxicity | Pass |

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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

7

ASTM D3578-19 Standard Specification for Rubber Examination Gloves ●
ASTM D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
ASTM D7160 Standard Practice for Determination of Expiration Dating for medical Gloves
ASTM D7161 Standard Practice for Determination of Expiration Date of Medical Gloves
. ISO 10993-1 : 2009 Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological Evaluation of Medical Devices - Part 5: Tests For systemic toxicity
ISO 15233-1-2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

VIII. CONCLUSION

The Conclusion drawn from the Non-Clinical test demonstrates that the subject device, Examination gloves-Type A (Latex gloves) is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K173053.