Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus solely on the physical properties and material standards of a medical glove, with no mention of AI or ML capabilities.

Therapeutic

No
The device is a medical glove intended for preventative purposes (preventing contamination), not for therapy or treatment.

Diagnostic

No

A medical glove is intended to prevent contamination, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical medical glove, which is a hardware device, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
Device Description: The provided description clearly states the device is a medical glove worn on the hand to prevent contamination between the patient and the examiner. It is a physical barrier used on the body.
Intended Use: The intended use is for preventing contamination during medical examinations, not for analyzing biological samples.

The description and intended use clearly place this device in the category of a general medical device, specifically a barrier device, rather than an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A medical glove is a disposable device intended for medical purposes that is worn on hand of the examiner's hand to prevent contamination between the patient and the examiner.

Product codes

LZA

Device Description

The proposed device is a powder free medical glove. The device is blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The difference between each size is just in the dimension. The proposed device is provided non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand

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)

Non clinical tests were conducted to verify that the proposed device met all design specifications and acceptance criteria in the test methodology and the standards. The test results demonstrated that the proposed device complies with the following standards and test methodology:

ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for MedicalApplication
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D3767-03 (2020) Standard Practice for Rubber-Measurement of Dimensions
ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
A ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritationand Skin Sensitization;
A ISO 10993-11:2017 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity;

Test Methodology, Purpose, Acceptance Criteria, Results (Pass/Fail):

ASTM D6319-19, ASTM D3767-03 (2020), Physical Dimensions,
- Width: XS 70±10 mm (Pass), S 80±10 mm (Pass), M 95±10 mm (Pass), L 110±10 mm (Pass), XL 120±10 mm (Pass)
- Length: XS 220mm min (Pass), S 220mm min (Pass), M 230mm min (Pass), L 230mm min (Pass), XL 230mm min (Pass)
- Thickness: Palm 0.05mm min (Pass), Finger 0.05mm min (Pass)
ASTM D6319-19, ASTM D412-16, Physical Properties,
- Before Aging: Tensile Strength 14MPa min (Pass), Ultimate Elongation 500% min (Pass)
- After Aging: Tensile Strength 14MPa min (Pass), Ultimate Elongation 400% min (Pass)
ASTM D5151-19, Freedom from Holes, Be free from holes when tested in accordance with ASTM D5151 (Pass)
ASTM D6124-06, Powder free residue, Less than 2mg per glove (Pass)
ISO 10993-10:2010, Irritation, Non-Irritating (Pass)
ISO 10993-10:2010, Sensitization, Non-Sensitizing (Pass)
ISO 10993-11:2009, System Toxicity, Non-toxicity (Pass)

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

Not Found

Predicate Device(s)

K031384

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.

January 11, 2022

Shandong Huiwosheng Health Technology Co.,Ltd Haitao Wu QA Director 50m East Of Chaoyang Road, Zhanqian Street, Linyi Chemical Industrial Park, Linzi Town Dezhou. Shandong 250000 China

Re: K213168

Trade/Device Name: Medical Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 18, 2021 Received: September 28, 2021

Dear Haitao Wu:

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,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K213168

Device Name Medical Examination Gloves

Indications for Use (Describe)

A medical glove is a disposable device intended for medical purposes that is worn on hand of the examiner's hand to prevent contamination between the patient and the 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

EF

PSC Publishing Services (301) 443-6740

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

3

510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K213168

1. Date of Preparation: 01/11/2022
1. Sponsor Identification

Shandong Huiwosheng Health Technology Co.,Ltd

50m east of Chaoyang Road, Zhanqian street, Linyi Chemical Park, Linzi Town, Linyi County, Dezhou City, Shandong Province, China

Establishment Registration Number: Not yet registered

Contact Person: Haitao Wu QA Director Tel: +86-18865233273 Email: haitao@kbt-cn.com

1. Identification of Proposed Device
  Trade Name: Medical Examination Gloves Common Name: POWDER FREE EXAMINATION GLOVES

Regulatory Information

Classification Name: polymer patient examination glove Classification: I; Product Code: LZA; Regulation Number: 21CFR 880.6250 Review Panel: General Hospital;

Indication for Use:

A medical glove is a disposable device intended for medical purposes that is worn on hand of the examiner's hand to prevent contamination between the patient and the examiner.

Device Description

The proposed device is a powder free medical glove. The device is blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in five sizes, which are XS, S, M, L, XL, it could be

4

selected by the user depended on size of hand. The difference between each size is just in the dimension. The proposed device is provided non-sterile.

1. Identification of Predicate Device
  510(k) Number: K031384

Product Name: MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES

ર. Technological Characteristics Comparison

ITEM	Proposed Device	Predicate Device	Remark
Product Code	LZA	LZA	Same
Regulation Number	21 CFR 880.6250	21 CFR 880.6250	Same
Class	I	I	Same
Indication for use	A medical glove is a disposable device intended for medical purposes that is worn on hand of the examiner's hand to prevent contamination between the patient and the examiner.	This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.	Same
Material	Polyurethane	Polyurethane	Same
Color	Blue	White	Analysis
1
Sterility	Non-sterile	Non-sterile	Same
Single-use	Yes	Yes	Same
Size	XS, S, M, L, XL	XS, S, M, L, XL	Same
Dimensions
(ASTM D6319-19)	Width
	XS	70±10mm	XS
	S	80±10mm	S
	M	95±10mm	M
	L	110±10mm	L
	XL	120±10mm	XL
	Length
	XS	220mm min	XS
	S	220mm min	S
M	230mm min	M

Table 1 Comparison of Technology Characteristics

5

	L	230mm min	L	all sizes
	XL	230mm min	XL
	Thickness
	Palm	0.05mm min	Palm	Min 0.13mm
	Finger	0.05mm min	Finger	Min 0.11mm
	Before Aging
	Tensile Strength	16.2 - 19.7MPa	Tensile Strength	16 – 23MPa	Analysis
3
Physical Properties
(ASTM D6319-19
And ASTM D412-

| Ultimate
Elongation | 642% - 754% | Ultimate
Elongation | 600% — 800% | |
| | | | | | |
| | | After Aging | | | |
| | Tensile Strength | 15.2 - 19.1MPa | Tensile Strength | 20 — 23MPa | |
| | Ultimate
Elongation | 552% - 662% | Ultimate
Elongation | 600% – 720% | |
| Powder free residue | | | | | |
| (ASTM D6319-19
And ASTM D6124-

                  | Less than 2mg per glove |                | Below 2mg/glove        |             | Same          |

Analysis 1- Color

The color of the proposed device is different from the predicate device.

Analysis 2- Dimensions

The dimension of the proposed device is not exactly same as the predicate device. The user can select appropriate model depended on size of user's hand.

Analysis 3- Physical Properties (ASTM D6319-19 and ASTM D412-16) The physical properties of the proposed device are not exactly same as the predicate device.

Analysis 4- Biocompatibility

The biocompatibility test item of the proposed device is different from the predicate device.

Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications and

6

acceptance criteria in the test methodology and the standards. The test results demonstrated that the proposed device complies with the following standards and test methodology:

ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for MedicalApplication
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D3767-03 (2020) Standard Practice for Rubber-Measurement of Dimensions
ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
A ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritationand Skin Sensitization;
A ISO 10993-11:2017 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity;

| Test Methodology | Purpose | Acceptance Criteria | | | Results
(Pass/Fail) |
|-------------------------------------------|---------------------|-----------------------------------------------------------------|------------------------|---------------|------------------------|
| ASTM D6319-19,
ASTM D3767-03
(2020) | Physical Dimensions | Width | XS | $70\pm10$ mm | Pass |
| | | | S | $80\pm10$ mm | |
| | | | M | $95\pm10$ mm | |
| | | | L | $110\pm10$ mm | |
| | | | XL | $120\pm10$ mm | |
| | | Length | XS | 220mm min | |
| | | | S | 220mm min | |
| | | | M | 230mm min | |
| | | | L | 230mm min | |
| | | | XL | 230mm min | |
| | | Thickness | Palm | 0.05mm min | |
| | | | Finger | 0.05mm min | |
| ASTM D6319-19,
ASTM D412-16 | Physical Properties | Before Aging | Tensile
Strength | 14MPa min | Pass |
| | | | Ultimate
Elongation | 500% min | |
| | | After Aging | Tensile
Strength | 14MPa min | |
| | | | Ultimate
Elongation | 400% min | |
| ASTM D5151-19 | Freedom from Holes | Be free from holes when tested in accordance with
ASTM D5151 | | | Pass |
| ASTM D6124-06 | Powder free residue | Less than 2mg per glove | | | Pass |

Table 2 Summary of non-clinical performance testing

7

ISO 10993-10:2010	Irritation	Non-Irritating	Pass
ISO 10993-10:2010	Sensitization	Non-Sensitizing	Pass
ISO 10993-11:2009	System toxicity	Non-toxicity	Pass

7. Clinical Test Conclusion

No clinical study is included in this submission.

1. Conclusion:
  The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe,

as effective, and performs as well as or better than the legally marketed predicate device K031384.