← Product Code [LYZ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ) · K210774
# Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K210774)
_Shandong Jieshi Medical Products Co., Ltd. · LYZ · May 14, 2021 · General Hospital · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K210774
## Device Facts
- **Applicant:** Shandong Jieshi Medical Products Co., Ltd.
- **Product Code:** [LYZ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ.md)
- **Decision Date:** May 14, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital
## Indications for Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
## Device Story
Device consists of disposable Poly Vinyl Chloride (PVC) film gloves. Function as physical barrier to prevent contamination between patient and examiner. Used in clinical settings by healthcare providers. PVC material provides water-tight barrier and tensile properties to conform to hand during medical procedures. No electronic or software components. Benefit is reduction of cross-contamination risk during examinations.
## Clinical Evidence
No clinical data. Bench testing only. Performance verified against ASTM D5151-19 (pinholes), ASTM D5250-06 (dimensions/physical properties), and ASTM D6124-06 (residual powder). Biocompatibility testing performed per ISO 10993-5:2009 (cytotoxicity) and ISO 10993-10:2010 (irritation and sensitization).
## Technological Characteristics
Material: Poly (vinyl chloride) (PVC). Form factor: Disposable gloves, sizes S-XL. Standards: ASTM D5250-06 (dimensions/physical properties), ASTM D5151-19 (pinholes), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-5, ISO 10993-10. Non-sterile. 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
- Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) ([K091663](/device/K091663.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). 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 14, 2021
Shandong Jieshi Medical Products Co.,Ltd % Chu Xiaoan Official Correspondent Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang, Chaoyung District Beijing, 100121 China
Re: K210774
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: February 8, 2021 Received: March 15, 2021
Dear Chu Xiaoan:
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.
{1}------------------------------------------------
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 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 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
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known)
K210774
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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)
## 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."
{3}------------------------------------------------
# 510(K) Summary
= "The assigned 510(k) number is: K210774
## Premarket Notification [510(k)] Summary
#### 1.0 Submitter:
| Submitter's name : | Shandong Jieshi Medical Products Co.,Ltd |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| Submitter's address : | North Road, Fumin Avenue, Qinghe Street,
Caoxian County,Heze City, Shandong
Province, 274400,P.R. China |
| Phone number : | 0086-530-2061157
0086-530-2069778 |
| Name of contact person: | Ms.Li Biao |
| Date of preparation : | 2021-02-08 |
#### 2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
|-------------------------|-------------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Common Name: | Vinyl Patient Examination Glove |
| Classification Name: | Non-powdered patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
#### 3.0 Predicate device
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
|----------------|-------------------------------------------------------------------|
| Company name: | Zhang Jia Gang Fengyuan Plastic Product Co. Ltd. |
| 510(K) Number: | K091663 |
#### 4.0 Device Description:
#### 4.1 How the device functions:
Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner
#### 4.2 Scientific concepts that form the basis for the device
The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
{4}------------------------------------------------
### 4.3 Physical and performance characteristics such as design, materials and physical properties:
The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
#### Indications for Use Statement: 5.0
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
#### 6.0 Summary of the Technological Characteristics of the Device:
Provided below is the Technological Characteristics Comparison Table that provides a comparison between the subject device and the predicate device.
| Features & Description | Predicate Device | Subject Device | Result of Comparison | | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Company | Zhang Jia Gang
Fengyuan Plastic
Product Co. Ltd. | Shandong Jieshi
Medical Products
Co.,Ltd | -- | | |
| 510(K) Number | K091663 | K210774 | -- | | |
| Product name | Powder Free Vinyl
Patient Examination
Gloves, Clear
(non-colored) | Powder Free Vinyl
Patient Examination
Gloves, Clear
(non-colored) | Similar | | |
| Product Code | LYZ | LYZ | Same | | |
| Size | Small/ Medium/
Large/X large | Small/ Medium/
Large/X large | Same | | |
| Intend for use | Powder Free Vinyl
Patient Examination
Gloves, Clear
(non-colored) 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. | Powder Free Vinyl
Patient Examination
Gloves,
Clear
(non-colored) 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. | Same | | |
| Device Description and
Specifications | Meets ASTM
D5250-06 | Meets ASTM
D5250-06
(Reapproved 2015) | Same | | |
| Dimensions Length
(mm)
ILS-2 AQL4.0 | $ ≥ $ 230mm | 231-241mm | 231-242mm | Similar | |
| Features & Description | | Predicate Device | Subject Device | Result of
Comparison | |
| Dimensions
Width
(mm) | Small | 80-90 | 81-89 | 82-89 | Similar |
| | Medium | 90-100 | 93-99 | 93-99 | |
| IL S-2 | Large | 100-110 | 102-110 | 103-109 | |
| AQL4.0 | X large | 110-120 | 111-1119 | 114-119 | |
| Dimensions
Thickness
(mm ) | Finger | ≥0.05 | 0.05-0.10 | 0.09-0.10 | Similar |
| IL S-2
AQL4.0 | Palm | ≥0.08 | 0.09-0.13 | 0.10-0.11 | |
| Physical | | | Before aging/after aging | | |
| Properties | Elongation ≥300% | | 380-410% | 350-420% | Similar |
| IL S-2 AQL4.0 | Tensile Strength
≥ 14MPa | | 16-20 MPa | 15-22 MPa | |
| Freedom from
Pinholes | Holes at
Inspection Level
I AQL2.5 | | Holes at
Inspection Level I
AQL2.5 | Holes at
Inspection Level I
AQL2.5 | Same |
| Residual
Powder | below 2mg of
residual powder | | 0.3mg | 0.1mg | Similar |
| Materials used to fabricate
the devices | | | PVC | PVC | Same |
| Performance data | | | Meets
ASTM D5151-06
(Reapproved 2011)
ASTM D5250-06
(Reapproved 2011)
ASTM D6124-06
(Reaffirmation 2011) | Meets
ASTM D5151-19
ASTM D5250-06
(Reapproved 2015)
ASTM D6124-06
(Reapproved 2017) | Same |
| Single Patient Use | Single Patient Use | Single Patient Use | Same | | |
| Biocompatibility | | | Under the conditions
of this study, not an
irritant and Under the
conditions of this
study, not a sensitizer. | Under the conditions
of this study, not an
irritant and Under
the conditions of
this study, not a
sensitizer. | Same |
| | | | SKIN IRRITATION
DERMAL and
SENSITIZATION
STUDIES Meets ISO
10993-10:2002/Amd.1
:2006 | SKIN IRRITATION
DERMAL and
SENSITIZATION
STUDIES Meets
ISO 10993-10 Third
Edition 2010-08-01
Under the conditions
of this study, the test
article was
non-cytotoxicity to
L-929 cells. | |
| Labeling | -Powder Free
-Patient Examination
Glove
-Single Use Only
- Manufactured For:
- Lot | -Powder Free
-Patient Examination
Glove
-Single Use Only
- Manufactured For:
- Lot | Same | | |
{5}------------------------------------------------
#### Summary of Non-Clinical Performance Data: 7.0
Non-clinical tests were conducted to verify that the proposed device will meet acceptance criteria for each test. The test results demonstrated that the proposed device met the acceptance criteria found in the following standards below:
{6}------------------------------------------------
| ISO 10993-5:2009 | 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. |
| ASTM D5151-19 | Standard Test Method for Detection of Holes in Medical
Gloves. |
| ASTM D5250-06
(Reapproved 2015) | Standard specification for poly (vinyl chloride) gloves for
medical application. |
| ASTM D6124-06
(Reapproved 2017) | Standard Test Method for Residual Powder on Medical
Gloves |
| Characteristics | Standard |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimension | ASTM D 5250-06(Reapproved 2015). |
| | Length ≥230mm |
| | Width
Small 80-90 mm
Medium 90-100mm
Large 100-110mm
X large 110-120 mm |
| | Thickness
Fingertip ≥0.05mm
Palm ≥0.08mm |
| | |
| | |
| | |
| Physical
Properties | ASTM D 5250-06(Reapproved 2015). |
| | Tensile strength (Before & After aging) ≥11MPa |
| | Elongated rate (Before & After aging) ≥300% |
| Freedom from
pinholes | 21 CFR 800.20 ASTM D5250-06(Reapproved 2015) ASTM D5151-19 Passed Standard Acceptance Criteria |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2015).and D6124-06(Reapproved 2017)
Meets <2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits
ISO 10993-10: 2010-08-01
Passes
Under the conditions of the study, the subject device is not a primary skin irritant. |
| | Dermal sensitization in the guinea pig
ISO 10993-10: 2010-08-01
Passes
Under the conditions of the study, the subject device is not a skin sensitizer. |
| | The test article was added to L929 cells
measured by MTT assay
ISO 10993-5: 2009
Pass
Under the conditions of this study, the test article was non-cytotoxicity to L-929 cells. |
### Summary of Clinical Performance Data: 8.0
Clinical testing is not needed for this device.
{7}------------------------------------------------
#### 9.0 Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.
---
**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K210774](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K210774)
**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