(422 days)
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.
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.
This document describes a 510(k) premarket notification for a medical device, specifically a Powdered Latex Surgeon's Glove. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through a comprehensive study with acceptance criteria and a detailed statistical analysis typically associated with AI/ML devices or new therapies.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission. The device is a physical product (a glove), not a software algorithm or AI.
However, I can extract the relevant information regarding performance specifications and how the device meets established standards.
Device Name: Powdered Latex Surgeon's Glove (Suzhou Colour-way Enterprise Development Co., Ltd)
Predicate Device: Powdered Latex Surgeon's Glove (K062797)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating equivalence to a predicate device and meeting the requirements of established international standards (ASTM D3577-0951, ISO10993-10:2010, and ISO11137-2:2012).
| Characteristic | Acceptance Criteria (Predicate Device / Standard) | Reported New Device Performance (Colour-way's Glove) |
|---|---|---|
| Physical Dimensions: | ||
| Length (various sizes) | Min. 245 mm to Min. 265 mm (depending on size) | 250 |
| Width (various sizes) | 70±6 mm to 114±6 mm (depending on size) | 72±4 mm to 114±6 mm (depending on size) |
| Thickness: | ||
| Cuff | Min. 0.10 mm | 0.21±0.1 mm |
| Palm | Min. 0.10 mm | 0.24±0.1 mm |
| Finger | Min. 0.10 mm | 0.25±0.1 mm |
| Before Ageing: | ||
| Tensile Strength | 24 MPa, min | 33~38 MPa |
| Ultimate Elongation | 750% min | 750~800% |
| Stress at 500% Elongation | 5.5 MPa, max | 5.2~5.4 MPa |
| After Ageing: | ||
| Tensile Strength | 18 MPa, min | 28~34 MPa |
| Ultimate Elongation | 560%, min | 740~810% |
| Water Leak | Inspection Level: I, AQL: 1.5 | Inspection Level: I, AQL: 1.5 |
| Biocompatibility: | ||
| Guinea Pig Maximization | No significant skin sensitization | No significant evidence of causing skin sensitization (as per ISO10993-10) |
| Primary Skin Irritation | Not irritating | Not irritating (as per ISO10993-10) |
| Sterilization Validation: | Meet acceptance criteria | Meet acceptance criteria (as per ISO 11137-2) |
| Powder Content | (Implicit from predicate description) | No more than 15mg/dm² |
| Extractable Protein | (Implicit from predicate description) | No more than 200µg/dm² |
Study Proving Device Meets Acceptance Criteria:
The submission explicitly states: "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." This indicates that the new device underwent testing to demonstrate compliance with these standards, and a comparison against the predicate device based on the characteristics listed above.
Information Not Applicable to this 510(k) Submission (Device is a Physical Product, not AI/ML):
Given that this is a 510(k) submission for a physical medical device (latex gloves) and not an AI/ML software device, the following categories are not applicable (N/A):
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A – Testing is on physical properties and biocompatibility, not data sets.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): N/A – Ground truth is established by physical measurements and standardized biochemical/biological tests, not expert interpretation of data.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A – Applies to interpretation tasks, not physical product testing.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A – Applies to AI/ML software.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A – Applies to AI/ML software.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A – Ground truth for physical properties are defined by test methods in the standards (e.g., force required to break, elongation percentage, chemical analysis results).
- 8. The sample size for the training set: N/A – Applies to AI/ML software.
- 9. How the ground truth for the training set was established: N/A – Applies to AI/ML software.
Summary of the Study (as presented in the 510(k)):
The "study" in this context is a series of tests performed to demonstrate that the Powdered Latex Surgeon's Glove manufactured by Suzhou Colour-way Enterprise Development Co., Ltd meets the specifications of ASTM D3577-0951, ISO10993-10:2010, and ISO11137-2:2012 standards, and that its technological characteristics (material, design, indications for use, and performance features like dimensions, tensile strength, elongation, water leak, and biocompatibility) are substantially equivalent to the identified predicate device (K062797). The specific details of the testing methodology (e.g., exact number of gloves tested for each property) are not provided in this summary but would be part of the full submission to show compliance with the cited standards. The conclusion explicitly states the device is "as safe and effective and performed as well as the referenced predicate device."
{0}------------------------------------------------
Suzhou Colour-way Enterprise Development Co., Ltd
83 Changping Road, Dongqiao Industrial Area, 215152, Suzhou, Jiangsu PRC TEL: 86-512-65371793; FAX: 86-512-65379978; E-mail: zhuyingqiu@hotmail.com
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: | zhuyingqiu@hotmail.com |
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
{1}------------------------------------------------
83 Changping Road, Dongqiao Industrial Area, 215152, Suzhou, Jiangsu PRC TEL: 86-512-65371793; FAX: 86-512-65379978; E-mail: zhuyingqiu@hotmail.com
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.
-
- Summary of the technological characteristics of the device compared to the predicate device
| Characteristics | New DeviceColour-way's Glove | Predicate DevicePowdered Latex Surgeon'sGlove (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 LatexSurgeon's Glove is adisposable device madeof natural rubberintended to be worn byoperating roompersonnel to protect asurgical wound fromcontamination. | This Powdered LatexSurgical Glove is adisposable device made ofnatural rubber latex materialthat bears powder to facilitatedonning, and it is intended tobe worn on the hands, usuallyin surgical setting, to providea barrier against potentiallyinfectious materials and othercontaminants. | |||
| 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 DeviceColour-way's Glove | Predicate DevicePowdered Latex Surgeon'sGlove (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 | |||
| BeforeAgeing | Tensile Strength | 33~38 MPa | 24MPa, min | ||
| UltimateElongation | 750~800% | 750% min | |||
| Stress at 500%Elongation | 5.2~5.4MPa | 5.5MPa, max | |||
| After Ageing | Tensile Strength | 28~34 MPa | 18 MPa, min | ||
| UltimateElongation | 740~810% | 560%, min | |||
| Water Leak | Inspection Level: IAQL: 1.5 | Inspection Level: IAQL: 1.5 | |||
| Biocompatibility | Guinea PigMaximization | Gloves showed nosignificant evidence ofcausing skinsensitization as perISO10993-10. | Gloves showed no significantevidence of causing skinsensitization. | ||
| Primary SkinIrritation | Gloves are notirritating as perISO10993-10. | Gloves are not irritating. | |||
| Sterilization validation | Meet acceptancecriteria as per ISO11137-2. | Meet acceptance criteria | |||
| Labeling Features | Include the requiredlabeling: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: 86-512-65371793; FAX: 86-512-65379978; E-mail: zhuyingqiu@hotmail.com
{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: 86-512-65371793; FAX: 86-512-65379978; E-mail: zhuyingqiu@hotmail.com
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.
{4}------------------------------------------------
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.
{5}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
{6}------------------------------------------------
Suzhou Colour-way Enterprise Development Co., Ltd 83 Changping Road, Dongqiso Industrial Area, 215152, Suzhou, Jiangsu PRC TEL: 86-512-65371793; FAX: 86-512-65379978; 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
§ 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).