BYTECH

K130101 · Bytech Dongtai Co., Ltd. · LYZ · Nov 8, 2013 · General Hospital

Device Facts

• Record ID: K130101
• Device Name: BYTECH
• Applicant: Bytech Dongtai Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Nov 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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 is a non-sterile, disposable patient examination glove made of PVC material. Worn by clinicians or examiners on hands/fingers to provide a barrier against contamination between patient and examiner. Used in clinical or general medical settings. Device is manually donned by the user. Benefits include protection against cross-contamination during medical examinations. No electronic or automated components.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including physical property testing (tensile strength, elongation), dimension verification, freedom from pinholes (ASTM D5151-06), residual powder testing (ASTM D6124-06), and biocompatibility studies (ISO 10993-10) for skin irritation and dermal sensitization.

Technological Characteristics

Material: PVC. Donning agent: Surface coating agent (PU). Standards: ASTM D5250-06 (Reapproved 2011), ASTM D5151-06, ASTM D6124-06, 21 CFR 800.20, ISO 10993-10. Form factor: Disposable, non-sterile, clear (non-colored) gloves in Small, Medium, Large, and X-large sizes. No energy source or connectivity.

Indications for Use

Indicated for use as a non-sterile, disposable patient examination glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Suitable for both prescription and over-the-counter use.

Regulatory Classification

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 Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. (K091663)

Submission Summary (Full Text)

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# Section C 510(k) Summary (21 CFR 807.92)

## 510(K) Summary

"This summary of 510(k) safety and cffectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

"The assigned 510(k) number is: K130101 11

Premarket Notification [5]0(k)] Summary

NOV 08 2013

| Submitter's name : | Bytech Dongtai Co.,Ltd. |
|--------------------------------|---------------------------------------------------------------------------------|
| Submitter's address : | Xing Yuan Industrial Park, Tang Yang Town, Dong Tai City, JiangSu, 224200 China |
| Phone number : | 0086-515-85655500 |
| Fax number : | 0086-515-85655500 |
| Name of contact person: | Mr. Wang Cheng |
| Date the summary was prepared: | 2013-09-29 |
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Proprietary/Trade name: | "Bytech" |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |

Class I* Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM D 5250-06 (Reapproved 2011).

Predicate device: Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. K091663.

Device Description: Powder Free Viny| Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material , intended for medical purpose that worn on examiner's hand or linger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).

' Section C (rev.01)

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Device Intended Use (Indication for use): Powder Free Viny) 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.

## A summary of the technological characteristics of new device compared to the predicate device.

The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

| Characteristics | Standard | Device performance |
|--------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Dimension | ASTM standard D<br>5250-06(Reapproved 2011). | Meets |
| Physical Properties | ASTM standard D<br>5250-06(Reapproved 2011). | Meets |
| Freedom from<br>pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06<br>(Reapproved 2011).<br>and D6124-06(Reapproved 2011). | Meets<br><2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbits<br>ISO 10993-10<br><br>Dermal sensitization in the guinea pig<br>ISO 10993-10 | Passes<br>The test article was non<br>irritant.<br><br>Passes<br>The test article was non<br>sensitizer. |

## A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), meet requirements per ASTM D5250-06 (Reapproved 2011), per ASTM D6124-06(Reapproved 2011), per 21 CFR 800.20 and ISO 10993-10: 2002/Amd. 1:2006.

The performance test data of the nonclinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

| Features &<br>Description | Predicate Device | Medical<br>Guidance<br>Manual(1661) | Glove Subject Device | Result of<br>Comparison |
|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Company | Zhang Jia<br>Fengyuan<br>Product Co.Ltd. | Gang<br>Plastic | Jiangsu Toptouch Glove<br>Co., Ltd. | -- |
| 510(K) Number | K091663 | | -- | |
| Product name | Powder Free Vinyl<br>Patient Examination<br>Gloves, Clear<br>(Non-colored) | | Powdered Free Vinyl<br>Patient Examination<br>Gloves, Clear<br>(non-colored) | same |
| Product Code | LYZ | LYZ | LYZ | same |
| Size | Small/ Medium/<br>Large/X large | | Small/ Medium/<br>Large/X large | same |
| Intend for use | Powder free Vinyl<br>Patient Examination<br>Gloves,<br>Clear(Non-colored)is a<br>disposable device | Powder Free<br>Examination Gloves:<br>A powder-free patient<br>examination glove is a<br>disposable device | Powder free Vinyl<br>Patient Examination<br>Gloves, Clear<br>(Non-colored) is a<br>disposable device | Substantially<br>equivalent |
| | intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | |
| Device Description and Specifications | Meets ASTM D5250-06<br>(Reapproved 2011) | If vinyl:<br>Do the vinyl examination gloves meet all the current specifications listed under ASTM Specification D5250 or an equivalent consensus standard? | Meets ASTM D5250-06<br>(Reapproved 2011) | Substantially equivalent |
| Dimensions<br>--Length | Meets ASTM D5250 -06<br>(Reapproved 2011)<br>≥230mm min | ASTM D5250 | 230mm min for all sizes | Substantially equivalent |
| Dimensions<br>-- Width | Meets ASTM D5250-06<br>(Reapproved 2011) | ASTM D5250 | | Substantially equivalent |
| | Small 80-90 mm<br>Medium 90-100mm<br>Large 100-110mm<br>Xlarge 110-120 mm | | Small 80-85 mm<br>Medium 95-100mm<br>Large 102-108mm<br>X large 113-118 mm | |
| Dimensions<br>--Thickness | Meets ASTM D5250-06<br>(Reapproved 2011)<br>Finger 0.05mm min.<br>Palm 0.08mm min. | | Thickness (mm) min.<br>Finger 0.09-0.12<br>Palm 0.09-0.12 | Substantially equivalent |
| Physical Properties | Meets ASTM D 5250-06<br>(Reapproved 2011)<br>Before aging/after aging<br>Elongation ≥300%<br>Tensile Strength≥ 14MPa | ASTM D5250 | Before aging/after aging<br>Elongation :390-420%<br>Tensile Strength:15-20 MPa | Substantially equivalent |
| Freedom from Pinholes | Meets<br>• 21 CFR 800.20<br>• ASTM D5250-06 (Reapproved 2011)<br>• ASTM D 5151-06 (Reapproved 2011) | 21 CFR 800.20<br>ASTM D5250<br>ASTM D 5151 | Meets ASTM D5151-06<br>(Reapproved 2011)<br>Holes at Inspection Level I<br>AQL2.5 | Substantially equivalent |
| Residual Powder | Meets ASTM D 6124-06<br>(Reapproved 2011)<br>below 2mg of residual powder | ASTM D 6124 | Meets ASTM D 6124-06<br>(Reapproved 2011)<br>Results generated values below 2mg of residual powder | Substantially equivalent |
| Materials used to fabricate the devices | PVC | If the glove is made of a polymer or other type of material. identify the material. | PVC | Substantially equivalent |
| Dusting or Donning | PU | If a donning lubricant is used state the | PU | Substantially equivalent |
| | | | | |
| Powder: | | composition<br>and include<br>biocompatibility data<br>for the lubricant in an<br>identified attachment;<br>also state the name,<br>manufacturer, and<br>address below | | |
| Dusting or<br>Donning<br>Powder: name | PU | Lubricant<br>Generic Name/<br>Lubricant<br>Brand Name | Surface Coating Agent | Substantially<br>equivalent |
| Compare<br>performance<br>data supporting<br>substantial<br>equivalence | Meets<br>ASTM D5151-06<br>(Reapproved 2011)<br>ASTM D5250-06<br>(Reapproved 2011)<br>ASTM D6124-06<br>(Reapproved 2011) | At this time FDA<br>recognizes the<br>following standards:<br>Patient Examination<br>Gloves(PVC)ASTM<br>D5151(Detection of<br>Holes in Medical<br>Gloves)ASTM<br>D6124(Residual<br>Powder on Medical<br>Gloves)ASTM<br>D5250(Poly(vinyl<br>chloride) Gloves) | Meets<br>ASTM D5151-06<br>(Reapproved 2011)<br>ASTM D5250-06<br>(Reapproved 2011)<br>ASTM D6124-06<br>(Reapproved 2011) | Substantially<br>equivalent |
| Single Patient<br>Use | Single Patient Use | Single Patient Use | Single Patient Use | Substantially<br>equivalent |
| Biocompatibility | SKIN IRRITATION<br>DERMAL and<br>SENSITIZATION<br>STUDIES Meets ISO<br>10993-10:2002/Amd.1:<br>2006 | SKIN IRRITATION<br>DERMAL and<br>SENSITIZATION<br>STUDIES<br>ISO 10993-10 | The test article was non<br>irritant and non<br>sensitizer.<br><br>SKIN IRRITATION<br>DERMAL and<br>SENSITIZATION<br>STUDIES Meets ISO<br>10993-10:2002<br>/Amd.1:2006 | Substantially<br>equivalent |
| Labeling for the<br>legally marketed<br>device to which<br>substantial<br>equivalence is<br>claimed | -Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot | Chapter 4 | -Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot | Substantially<br>equivalent |

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A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

#### The conclusions

It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) mcct the ASTM standard or cquivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.

It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, Powder-Free Viny] Patient Examination Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. K091663.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a globe, representing the department's mission to protect the health of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W()66-G609 Silver Spring, MD 20993-0002

November 8, 2013

Bytech Dongtai Company, Limited Mr. Wang Cheng Quality Department Manager Xing Yuan Industrial Park. Tang Yang Town Dong Tai City, JiangSue CHINA 224200

Re: K130101

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LYZ Dated: September 29, 2013 Received: October 2, 2013

Dear Mr. Cheng:

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. 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 vour device is classified (see above) into cither 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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Page 2 - Mr. Cheng

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.lda.gov/MedicalDevices/Safetv/ReportalProblem/default.hum for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Image /page/5/Picture/7 description: The image shows a signature and some text. The text includes "Sincerely yours," followed by the name "Tejashri Purohit-Sheth, M.D." and the title "Clinical Deputy Director." The acronym "DAGRID" is also present. Finally, the word "FOR" is at the bottom right.

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K130101

#### Device Name

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

#### Indications for Use (Describe)

Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purpose 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)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

. . . . . . . . . . . . . . . FOR EDA USE ONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/6/Picture/13 description: The image shows the name "Elizabeth F. Claverie" in bold, black font. Below the name, the date "2013.11.07" and the time "21:50:02" are printed in a similar font. There is a logo to the right of the name and date, but it is difficult to read.