POWDERED LATEX SURGEON'S GLOVE

• K Number: K121925
• Device Name: POWDERED LATEX SURGEON'S GLOVE
• Manufacturer: SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD.
• Date Cleared: 2013-08-28 ( 422 days)
• Product Code: KGO
• Regulation Number: 878.4460

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 Description

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.

Predicate Devices

K062797

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No.
The device is a disposable surgeon's glove intended to protect a surgical wound from contamination, which is a barrier function, not a therapeutic one.

Diagnostic

No

A surgeon's glove is used to protect a surgical wound from contamination, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical glove made of natural rubber latex, not software. The description focuses on material properties and physical performance characteristics.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is clearly stated as "to be worn by operating room personnel to protect a surgical wound from contamination." This describes a physical barrier function for protection during surgery.
• Device Description: The description focuses on the material (natural rubber latex), form (glove), and physical properties (powdered, sterile, meets ASTM standards).
• Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not interact with bodily specimens in this way.

The information provided describes a medical device used for personal protection and maintaining a sterile environment during surgery, not a diagnostic test performed on biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

KGO

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room personnel

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)

Not Applicable

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K062797

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
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.(b)
Classification. Class I (general controls).

Summary

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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
Colour-way's Glove | Predicate Device
Powdered Latex Surgeon's
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
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. | This Powdered Latex
Surgical Glove is a
disposable device made of
natural rubber latex material
that bears powder to facilitate
donning, and it is intended to
be worn on the hands, usually
in surgical setting, to provide
a barrier against potentially
infectious materials and other
contaminants. | | |
| | | Length | 5.5 | 250280 mm | Min.245 mm |
| | | | 6 | 260290 mm | Min.265 mm |
| | | | 6.5 | 260290 mm | Min.265 mm |
| | | | 7 | 270300 mm | Min.265 mm |
| 7.5 | 270300 mm | | Min.265 mm | | |
| 8 | 270300 mm | | Min.265 mm | | |
| 8.5 | 280310 mm | | Min.265 mm | | |
| 9 | 280310 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
Colour-way's Glove | Predicate Device
Powdered Latex Surgeon's
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
Ageing | Tensile Strength | 3338 MPa | 24MPa, min | | |
| | Ultimate
Elongation | 750800% | 750% min | | |
| | Stress at 500%
Elongation | 5.25.4MPa | 5.5MPa, max | | |
| After Ageing | Tensile Strength | 2834 MPa | 18 MPa, min | | |
| | Ultimate
Elongation | 740~810% | 560%, min | | |
| Water Leak | | Inspection Level: I
AQL: 1.5 | Inspection Level: I
AQL: 1.5 | | |
| Biocompatibility | Guinea Pig
Maximization | Gloves showed no
significant evidence of
causing skin
sensitization as per
ISO10993-10. | Gloves showed no significant
evidence of causing skin
sensitization. | | |
| | Primary Skin
Irritation | Gloves are not
irritating as per
ISO10993-10. | Gloves are not irritating. | | |
| Sterilization validation | | Meet acceptance
criteria as per ISO
11137-2. | Meet acceptance criteria | | |
| Labeling Features | | Include the required
labeling:
Surgeon's Gloves,
Sterile,
Disposable. | Include the required labeling:
Surgeon's Gloves,
Sterile,
Disposable,
Powdered. | | |

2

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]

3

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