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 material standards of examination gloves, with no mention of AI or ML.

Therapeutic

No
The device is described as examination gloves intended to prevent contamination, not to treat or diagnose a medical condition.

Diagnostic

No

This device is described as an examination glove intended to prevent contamination, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device is described as physical examination gloves, which are a hardware medical device, 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 to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a barrier function for personal protection, not a diagnostic test performed on a sample taken from the body.
Device Description: The description is of a physical barrier (gloves) and its characteristics (material, color, size, sterility). It does not describe a reagent, instrument, or system used to examine specimens from the human body.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions

The device is clearly described as a medical device intended for barrier protection during examinations.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Nitrile Examination Golves Powder Free is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Product codes

LZA

Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiners

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:
ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
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 11: Tests for systemic toxicity.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves.
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

The tests included Physical Dimensions Test (ASTM D6319), Watertightness Test for Detection of Holes (ASTM D5151), Powder Content (ASTM D6124), Physical properties (ASTM D412), Cytotoxicity (ISO 10993-11), Irritation (ISO 10993-10), and Sensitization (ISO 10993-10). All tests passed their respective acceptance criteria.

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

Length (mm): S: >=220; M/L/XL: >=230; Width (mm): S: 80+/-10; M: 95+/-10; L: 110+/-10; XL: 120+/-10; Thickness (mm): Finger: >=0.05; Palm: >=0.05.
Watertightness Test for Detection of Holes: AQL 2.5, Results: 0/200/Pass.
Powder Content: =14MPa, Results: 23.3-35.2/Pass; Ultimate Elongation >=500%, Results: 496-529/Pass.
Physical Properties (After Aging): Tensile Strength >=14MPa, Results: 20.0-44.5/Pass; Ultimate Elongation >=400%, Results: 450-500/Pass.
Cytotoxicity: Non-acute systemic toxicity, Results: Under conditions of the study, did not show acute systemic toxicity in vivo / Pass.
Irritation: Non-irritating, Results: Under the conditions of the study, not an irritant/ Pass.
Sensitization: Non-sensitizing, Results: Under conditions of the study, not a sensitizer./ Pass.

Predicate Device(s)

K203593

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

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

December 24, 2021

Jiangsu Standard Health Co.,Ltd % Boyle Wang official Correspondent Shanghai Truthful information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K212921

Trade/Device Name: Nitrile Examination Golves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 15, 2021 Received: November 18, 2021

Dear Boyle Wang:

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,

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 Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K212921

Device Name Nitrile Examination Golves Powder Free

Indications for Use (Describe)

The Nitrile Examination Golves Powder Free is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

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 K212921

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

1.0 Submitter's Information

Name: Jiangsu Standard Health Co.,Ltd Address: 19F Fortune Tower, No.1 Wangxi Road, Zhangjiagang City, Jiangsu, China Phone Number: +86-0512-58585333 Contact: Lu Tao Date of Preparation: Sept 6,2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Nitrile Examination Golves Powder Free Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL

3.0 Classification

Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

4.0 Predicate Device Information

Manufacturer: GUANG DONG KINGFA SCI. & TECH.CO., LTD. Device: Nitrile examination gloves 510(k) number: K203593

5.0 Indication for Use

4

The Nitrile Examination Golves Powder Free is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

6.0 Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

7.0 Technological Characteristic Comparison Table

| Item | Subject Device
(K212921) | Predicated Device
(K203593) | Remark |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Nitrile Examination
Golves Powder Free is
intended to be worn on
the hands of examiners
to prevent contamination
between patient and
examiner. This is a
single-use, powder-free,
non-sterile device. | The nitrile examination
glove is intended to be
worn on the hands of
examiners to
prevent contamination
between patient and
examiner. This is a
single-use, powder-free,
non-sterile device. | Same |
| Material | Nitrile | Nitrile | Same |
| Powdered or
Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Blue | Blue | Same |
| Labeling
Information | Single-use indication,
powder free, device
color, device name,
glove size and quantity,
Non-Sterile | Single-use indication,
powder free, device
color, device name,
glove size and quantity,
Non-Sterile | Same |
| Dimensions(mm) | Length:
S:≥220;
M/L/XL: ≥230;
Width:
S: 80±10;
M: 95±10;
L: 110±10; | Length:
S:≥220;
M/L/XL: ≥230;
Width:
S: 80±10;
M: 95±10;
L: 110±10; | Same |

Table1-General Comparison

5

		XL: 120±10
Thickness(mm)		Finger: ≥0.05;
Palm: ≥0.05	Finger: ≥0.05;
Palm: ≥0.05	Same

Physical
Properti
es	Before
Aging	Tensile
Strength	14MPa,
min	Tensile
Strength	14MPa,
min	Same
		Ultimate
Elongation	500% min	Ultimate
Elongation	500% min	Same
	After
Aging	Tensile
Strength	14MPa,
min	Tensile
Strength	14MPa,
min	Same
		Ultimate
Elongation	400%min	Ultimate
Elongation	400%min	Same
Freedom from
Holes		Be free from holes when
tested in accordance
with ASTMD5151
AQL=2.5		Be free from holes when
tested in accordance
with ASTMD5151
AQL=2.5		Same
Powder Content		Meet the requirements of
ASTM D6124		Meet the requirements of
ASTM D6124		Same
Biocompatibility		ISO 10993-10;
Under the conditions of
the study, not an irritant
or a sensitizer
ISO 10993-11;
Under the
condition of acute
systemic toxicity test,
the test article did not
show acute systemic
toxicity in vivo.
ISO 10993-5
Under conditions of the
study, device extract is
cytotoxic		ISO 10993-10;
Under the conditions of
the study, not an irritant
or a sensitizer
ISO 10993-11;
Under the
condition of acute
systemic toxicity test,
the test article did not
show acute systemic
toxicity in vivo.
ISO 10993-5
Under conditions of the
study, device extract is
cytotoxic		Same

8.0 Summary of Non-clinical Testing

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:

ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

6

ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves

ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

| Test

Method	Purpose	Acceptance Criteria	Results
ASTM
D6319	Physical
Dimensions
Test	Length(mm):
S:≥220;
M/L/XL:≥230;	Length(mm):

230/Pass; |
| | | Width(mm):
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10 | Width(mm):
S: 86-87 /Pass
M: 97-98/ Pass
L: 107-108/ Pass
XL:115-116/ Pass |
| | | Thickness (mm):
Finger: ≥0.05
Palm: ≥0.05 | Thickness (mm):
S:
Finger: 0.10-0.11/Pass
Palm: 0.06-0.07/Pass
M:
Finger: 0.11-0.12/Pass
Palm: 0.06-0.07/Pass
L:
Finger: 0.11-0.12/Pass
Palm: 0.06-0.07/Pass
XL:
Finger: 0.11-0.12/Pass
Palm: 0.07/Pass |
| ASTM
D5151 | Watertightness
Test for
Detection of
Holes | Meet the requirements of ASTM D5151
AQL 2.5 | 0/200/Pass |
| ASTM
D6124 | Powder
Content | Meet the requirements of ASTM D6124