← Product Code [LZA](/productcode/LZA) · K213168
# Medical Examination Gloves (K213168)
_Shandong Huiwosheng Health Technology Co.,Ltd · LZA · Jan 11, 2022 · General Hospital · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K213168
## Device Facts
- **Applicant:** Shandong Huiwosheng Health Technology Co.,Ltd
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Jan 11, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital
## 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.
## Device Story
Disposable, non-sterile, powder-free polyurethane medical examination glove; blue color; available in sizes XS, S, M, L, XL. Worn by healthcare personnel during examinations to provide a barrier against contamination. Device functions as a physical barrier; no electronic or software components. Performance verified through bench testing for physical dimensions, tensile strength, elongation, freedom from holes, and biocompatibility.
## Clinical Evidence
No clinical data. Bench testing only. Testing included physical dimensions (ASTM D6319-19, D3767-03), physical properties (ASTM D412-16), freedom from holes (ASTM D5151-19), residual powder (ASTM D6124-06), and biocompatibility (ISO 10993-10, ISO 10993-11). All tests met acceptance criteria.
## Technological Characteristics
Material: Polyurethane. Form factor: Disposable, non-sterile, powder-free glove. Sizes: XS-XL. Standards: ASTM D6319-19, ASTM D5151-19, ASTM D3767-03, ASTM D412-16, ASTM D6124-06, ISO 10993-10, ISO 10993-11. No energy source, connectivity, or software.
## Regulatory 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.
## Predicate Devices
- MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES ([K031384](/device/K031384.md))
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).
{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
- 2. 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
- 3. 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.
- 4. 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-
16) | 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-
06) | Less than 2mg per glove | | Below 2mg/glove | | Same |
| Freedom from Holes
(ASTM D5151-19) | Meet AQL 2.5 | | Pass GI
AQL=2.5 | | Same |
| | | | | | |
| Biocompatibility | | | | | |
| Skin Irritation | No Irritation | | No Irritation | | |
| Sensitization | No Sensitization | | No Sensitization | | Analysis
4 |
| System Toxicity | No Toxicity | | / | | |
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.
- 8. 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.
---
**Source:** [https://fda-staging.innolitics.com/device/K213168](https://fda-staging.innolitics.com/device/K213168)
**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).
**Cite:** Innolitics at https://innolitics.com