POWDERED LATEX SURGEON'S GLOVE

K121925 · Suzhou Colour-Way Enterprise Development Co., Ltd. · KGO · Aug 28, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K121925
• Device Name: POWDERED LATEX SURGEON'S GLOVE
• Applicant: Suzhou Colour-Way Enterprise Development Co., Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Aug 28, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

This Powdered Latex Surgeon's Glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Disposable surgeon's glove; manufactured from natural rubber latex; powdered with absorbable dusting powder to facilitate donning; ivory color; beaded cuff design. Used by operating room personnel in surgical settings to provide a barrier against infectious materials and contaminants. Sterilized via radiation. Single-use only. Provides physical protection for surgical wounds.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ASTM D3577-0951 (physical dimensions, tensile strength, elongation, water leak), ISO 10993-10 (biocompatibility), and ISO 11137-2 (sterilization). Powder content ≤15mg/dm²; extractable protein ≤200µg/dm².

Technological Characteristics

Material: Natural rubber latex. Design: Beaded cuff, powdered. Sterilization: Radiation (ISO 11137-2). Standards: ASTM D3577-0951. Dimensions: 250-310mm length, 72-114mm width depending on size. Thickness: 0.21-0.25mm. Mechanical: Tensile strength 28-38 MPa, elongation 740-810%.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. Contraindicated for individuals with natural rubber latex allergies.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Powdered Latex Surgeon's Glove (K062797)

Submission Summary (Full Text)

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# Suzhou Colour-way Enterprise Development Co., Ltd

83 Changping Road, Dongqiao Industrial Area, 215152, Suzhou, Jiangsu PRC TEL: [phone]; FAX: [phone]; E-mail: [e-mail]

# 510(k) Summary

The assigned 510(k): K121925

## 1. Submitter

| Name: | Suzhou Colour-way Enterprise Development Co., Ltd |
|------------------------|-----------------------------------------------------------------------------|
| Address: | 83 Changping Road, Dongqiao Industrial Area, 215152, Suzhou, Jiangsu, China |
| TEL: | 86-512-65371793 |
| FAX: | 86-512-65379978 |
| Date summary prepared: | June 14, 2013 |

## 2. Contact person

| Name: | Miss Zhu Yingqiu |
|---------|------------------------|
| TEL: | 86-512-65371793 |
| FAX: | 86-512-65379978 |
| E-mail: | [e-mail] |

# 3. Device Identification

Trade name: Powdered Latex Surgeon's Glove Common name: Surgeon's glove Classification name: Surgeon's glove Classification number: KGO, class I Regulation number: 21CFR 878.4460

# 4. Identification of the Predicate device

Trade name: Powdered Latex Surgeon's Glove 510(k) number: K062797 Product code: KGO

# 5. Description of the Device

The glove is made of natural rubber latex. It is powdered with absorbable dusting powder. The sterility status is sterile. It meets all the requirements of ASTM D3577-0951. No colorant is added during manufacture of our Powdered Latex Surgeon's Glove. The color of our glove is ivory.

# 6. Directions for use:

The product is made of natural rubber latex which may cause allergic reactions. It is powdered with absorbable dusting powdered Latex Surgeon's Glove is sterilized by radiation. It is single use only, and can not be reused. Don't use if the package is damaged.

AUG 28 2013

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83 Changping Road, Dongqiao Industrial Area, 215152, Suzhou, Jiangsu PRC TEL: [phone]; FAX: [phone]; E-mail: [e-mail]

# 7. Indications for Use:

This Powdered Latex Surgeon's Glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

- 8. Summary of the technological characteristics of the device compared to the predicate device

| Characteristics | | New Device<br>Colour-way's Glove | Predicate Device<br>Powdered Latex Surgeon's<br>Glove (K062797) | | |
|--------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------|
| Material Composition | | Natural Rubber Latex | Natural Rubber Latex | | |
| Colorant | | No colorant | No colorant | | |
| Design | | Single use | Single use | | |
| | | Sterile | Sterile | | |
| | | Powdered | Powdered | | |
| | | Beaded Cuff | Beaded Cuff | | |
| Indications for Use | | This Powdered Latex<br>Surgeon's Glove is a<br>disposable device made<br>of natural rubber<br>intended to be worn by<br>operating room<br>personnel to protect a<br>surgical wound from<br>contamination. | This Powdered Latex<br>Surgical Glove is a<br>disposable device made of<br>natural rubber latex material<br>that bears powder to facilitate<br>donning, and it is intended to<br>be worn on the hands, usually<br>in surgical setting, to provide<br>a barrier against potentially<br>infectious materials and other<br>contaminants. | | |
| | | Length | 5.5 | 250~280 mm | Min.245 mm |
| | | | 6 | 260~290 mm | Min.265 mm |
| | | | 6.5 | 260~290 mm | Min.265 mm |
| | | | 7 | 270~300 mm | Min.265 mm |
| 7.5 | 270~300 mm | | Min.265 mm | | |
| 8 | 270~300 mm | | Min.265 mm | | |
| 8.5 | 280~310 mm | | Min.265 mm | | |
| 9 | 280~310 mm | | Min.265 mm | | |
| Width | 5.5 | 72±4 mm | 70±6 mm | | |
| | 6 | 77±5 mm | 76±6 mm | | |
| | 6.5 | 83±5 mm | 83±6 mm | | |
| | 7 | 89±5 mm | 89±6 mm | | |
| Characteristics | | New Device<br>Colour-way's Glove | Predicate Device<br>Powdered Latex Surgeon's<br>Glove (K062797) | | |
| | 7.5 | 95±5 mm | 95±6 mm | | |
| | 8 | 102±6 mm | 102±6 mm | | |
| | 8.5 | 108±6 mm | 108±6 mm | | |
| | 9 | 114±6 mm | 114±6 mm | | |
| Thickness | Cuff | 0.21±0.1 mm | Min. 0.10 mm | | |
| | Palm | 0.24±0.1 mm | Min.0.10 mm | | |
| | Finger | 0.25±0.1 mm | Min.0.10 mm | | |
| Before<br>Ageing | Tensile Strength | 33~38 MPa | 24MPa, min | | |
| | Ultimate<br>Elongation | 750~800% | 750% min | | |
| | Stress at 500%<br>Elongation | 5.2~5.4MPa | 5.5MPa, max | | |
| After Ageing | Tensile Strength | 28~34 MPa | 18 MPa, min | | |
| | Ultimate<br>Elongation | 740~810% | 560%, min | | |
| Water Leak | | Inspection Level: I<br>AQL: 1.5 | Inspection Level: I<br>AQL: 1.5 | | |
| Biocompatibility | Guinea Pig<br>Maximization | Gloves showed no<br>significant evidence of<br>causing skin<br>sensitization as per<br>ISO10993-10. | Gloves showed no significant<br>evidence of causing skin<br>sensitization. | | |
| | Primary Skin<br>Irritation | Gloves are not<br>irritating as per<br>ISO10993-10. | Gloves are not irritating. | | |
| Sterilization validation | | Meet acceptance<br>criteria as per ISO<br>11137-2. | Meet acceptance criteria | | |
| Labeling Features | | Include the required<br>labeling:<br>Surgeon's Gloves,<br>Sterile,<br>Disposable. | Include the required labeling:<br>Surgeon's Gloves,<br>Sterile,<br>Disposable,<br>Powdered. | | |

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# Suzhou Colour-way Enterprise Development Co., Ltd

83 Changping Road, Dongqiao Industrial Area, 215152, Suzhou, Jiangsu PRC TEL: [phone]; FAX: [phone]; E-mail: [e-mail]

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# Suzhou Colour-way Enterprise Development Co., Ltd

Predicate Device New Device Powdered Latex Surgeon's Characteristics Colour-way's Glove Glove (K062797) Powdered Natural rubber latex allergy Natural rubber latex warning, Name and Place of Business, allergy warning, Name and Place of Country of Origin, etc Business, Country of Origin, etc

83 Changping Road, Dongqiao Industrial Area, 215152, Suzhou, Jiangsu PRC TEL: [phone]; FAX: [phone]; E-mail: [e-mail]

Based on the above comparison, the Colour-way Powdered Latex Surgeon's Glove is equivalent to the predicate device with respect to technology characteristics such as material, design, intended use, specification and performance features. It is as safe and effective and performed as well as the referenced predicate device.

### 9. Clinical Data

Not Applicable

#### 10. Conclusions

The Powdered Latex Surgeon's Glove manufactured by Suzhou Colour-way Enterprise Development Co., Ltd and the predicate device meet the technology characteristics of ASTM D3577-0951, ISO10993-10:2010 and ISO11137-2:2012 standards. Besides, our Powdered Latex Surgeon's Glove contains no more than 15mg/dm² powder and no more than 200µg/dm² extractable protein. Consequently, the device is substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

August 28, 2013

Suzhou Colour-Way Enterprise Development Company. Limited Ms. Zhu Yingqiu 83 Changping Road Dongqiao Industrial Area Suzhou, Jiangsu PR China 215152

Re: K121925

Trade/Device Name: Powdered Latex Surgeon's Glove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 21, 2013 Received: August 26, 2013

Dear Ms. Yingqiu:

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 10 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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.

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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 (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.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner - S

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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Suzhou Colour-way Enterprise Development Co., Ltd 83 Changping Road, Dongqiso Industrial Area, 215152, Suzhou, Jiangsu PRC TEL: [phone]; FAX: [phone]; E-mail: zhuyingqiu:@botmail.com

## Indications for Use Statement

K121925 510(k) Number (if known): Device Name: Powdered Latex Surgeon's Glove Indications For Use: This Powdered Latex Surgeon's Glove is a disposable device made of natural nibber intended to be worn by operating room personnel to protect a surgical wound from contamination.

AND/OR Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 301 Subpart D)

.. . . . . .

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Sreekanth Gutala - S 2013.08.28 12:05:22 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number._ K121925