(153 days)
Not Found
No
The device description and performance studies focus on material properties, sterilization, and physical performance standards for surgical gloves, with no mention of AI or ML.
No.
The device protects against contamination, but it does not treat a disease or condition.
No
This device is described as a surgical glove intended to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device description clearly states the device is made of natural rubber latex and is a physical glove, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside of the body (in vitro).
- Device's Intended Use: The intended use of this device is to be worn by operating room personnel to protect a surgical wound from contamination. This is a barrier device used on the body (specifically, on the hands) and is not involved in analyzing biological specimens.
- Device Description: The description focuses on the physical properties of the glove (material, sterilization, size, color) and its function as a protective barrier. There is no mention of analyzing or testing biological samples.
- Lack of IVD-related information: The document does not include any information typically associated with IVDs, such as:
- Analysis of biological samples
- Detection of analytes
- Diagnostic claims
- Performance metrics like sensitivity, specificity, etc. (which are relevant to diagnostic accuracy)
This device is a medical device, specifically a surgical glove, but it falls under a different classification than IVDs.
N/A
Intended Use / Indications for Use
A latex surgeon's glove is a 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 proposed device. Latex Surgeon's Gloves Powdered is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is made of natural rubber latex, per standard ASTM D3577-096', the rubber surgical gloves classification is:
"Type I - gloves compounded primarily from natural rubber latex"
The proposed device is Powdered Latex Surgeon's Gloves, and variations of different size. All variations share the same color, creamy white.
The proposed device is provided Gamma radiation sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and place in a sterility maintenance package to ensure a shelf life of 3 years.
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)
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM D3577-09e1. Standard Specification for Rubber Surgical Gloves.
- ASTM D5151 -06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reaffirmation 2011) Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D5712-10 Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
- ASTM D7160-05 (Reapproved 2010) standard practice for determination of expiration dating for medical gloves.
- ASTM F 1929-98 (2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
- ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible barrier Materials.
- ASTM D3078-02 (Reapproved 2013) standard test method for determination of leaks in flexible packaging by bubble emission.
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10 : Tests for irritation and skin sensitization.
- ISO 11137-2:2006 Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose
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.
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
§ 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).
0
Image /page/0/Picture/1 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines representing the concept of health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2015
Shanghai Jinxiang Latex Products Co., Ltd. c/o Mr. Chu Xiaoan Beijing Easy-link Company Building 41, Room F302, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang Chaoyang District, Beijing, 100121 CHINA
Re: K142992 Trade/Device Name: TULIP Natural Rubber Latex Surgeon's Glove (Powdered) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's glove Regulatory Class: I Product Code: KGO Dated: February 1, 2015 Received: February 19, 2015
Dear Mr. 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. 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
Page 2 - Mr. Xiaoan
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 devicerelated 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation 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) K142992
Device Name
TULIP Natural Rubber Latex Surgeon's Glove (Powdered)
Indications for Use (Describe)
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
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)
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3
Section C 510(k) Summary
510(K) Summary
The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
Application Correspondent
Mr. Chu xiaoan Beijing Easy-Link Company Tel: Fax: +86-10-82387441 Email: easylink_bj@sina.com
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Shanghai Jinxiang Latex Products Co., Ltd. |
|---|---|
| Submitter's address : | No.36 Leizhou Road, Xinghuo Development |
| Area, Fengxian District, Shanghai 201419, | |
| P.R. China | |
| Phone number : | 86-21-57127613 |
| Fax number : | 86-21-55092607 |
| Name of contact person: | Ms.Wang Xiaoyan |
| Date of preparation : | 2015-03-18 |
Name of the Device 2.0
| Device Name: | Natural Rubber Latex Surgeon's Gloves (Powdered) |
|---|---|
| Proprietary/Trade name: | TULIP Natural Rubber Latex Surgeon's Glove (Powdered) |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 878.4460 |
| Panel: | General& Plastic Surgery |
| Product Code: | KGO |
| Predicate device |
3.0
| 510(K) Number: | K063757 |
|---|---|
| Device Name: | Motex Powder-Free Surgical Gloves & Powdered |
| Latex Surgical Gloves | |
| Company name: | SHANGHAI MOTEX HEALTHCARE CO., LTD. |
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4.0 Device Description:
The proposed device. Latex Surgeon's Gloves Powdered is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination
The proposed device is made of natural rubber latex, per standard ASTM D3577-096', the rubber surgical gloves classification is:
"Type I - gloves compounded primarily from natural rubber latex"
The proposed device is Powdered Latex Surgeon's Gloves, and variations of different size. All variations share the same color, creamy white.
The proposed device is provided Gamma radiation sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and place in a sterility maintenance package to ensure a shelf life of 3 years.
5.0 Device Intended Use (Indication for use):
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
6.0 Summary of the Technological Characteristics of the Device:
The sterile Latex Surgeon's Gloves Powdered is summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance | ||
|---|---|---|---|---|
| Dimension | ASTM standard D 3577-091 | |||
| --Palm width | Size | (mm) | (mm) | |
| 6 | 76±6 | 73-80 | ||
| 6½ | 83±6 | 80-85 | ||
| 7 | 89±6 | 86-90 | ||
| 7½ | 95±6 | 92-98 | ||
| 8 | 102±6 | 100-104 | ||
| 8½ | 108±6 | 106-111 | ||
| --Length | ≥265mm min | 273-297 | ||
| --Thickness fingertip | ≥0.10mm min | 0.22-0.31 | ||
| --Thickness palm | ≥0.10mm min | 0.22-0.30 | ||
| --Thickness cuff | ≥0.10mm min | 0.20-0.30 | ||
| Physical Properties | ASTM standard D 3577-091 | |||
| Before Aging | After Aging | Before Aging | After Aging | |
| --Tensile Strength | 24Mpa | 18Mpa (min) | 26-30Mpa | 21-25Mpa (min) |
| --Stress at 500% elongation | 5.5Mpa(MAX) | -- | 3.5-4.0Mpa | -- |
| --Ultimate elongation | 750% | 560% (min) | 800-890% | 650-780% |
| Freedom from pinholes | 21 CFR 800.20 | Passed Standard Acceptance Criteria | ||
| Powder Amount | D6124-06(Reaffirmation 2011) | Meets | ||
| ≤15 mg/dm2 | ||||
| Protein Level | ASTM standard D 5712-10 | Meets | ||
| ≤200 µg/dm² | ||||
| Biocompatibility | Primary Skin Irritation in rabbits | |||
| ISO 10993-10: 2010-08-01 | Passes | Not a Primary Skin Irritation |
Table I Technological Characteristics
5
| | Dermal sensitization in the guinea pig ISO 10993-10: 2010-08-01 | Passes
Not a Dermal sensitization |
|--------------------------|-----------------------------------------------------------------|---------------------------------------------|
| Sterilization Validation | ISO 11137-1:2006 | Sterility Assurance Level (SAL) of
10-6. |
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM D3577-09e1. Standard Specification for Rubber Surgical Gloves.
- ASTM D5151 -06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reaffirmation 2011) Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D5712-10 Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
- ASTM D7160-05 (Reapproved 2010) standard practice for determination of expiration dating for medical gloves.
- ASTM F 1929-98 (2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
- ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible barrier Materials.
- ASTM D3078-02 (Reapproved 2013) standard test method for determination of leaks in flexible packaging by bubble emission.
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10 : Tests for irritation and skin sensitization.
- ISO 11137-2:2006 Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose
The performance test data of the nonclinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:
Clinical data was not including in this submission.
Substantial Equivalence Comparison: 9.0
Table II Substantially Equivalent Comparison
| Item | Proposed Device | Predicate Device
(K063757) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Product Code | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | Same |
| Class | I | Same |
| Intended Use | A latex surgeon's glove is a device made
of natural rubber intended to be worn by
operating room personnel to protect a
surgical wound from contamination. | Similar |
| Powdered | Only Powdered(no Powdered free) | Powdered and
Powdered-free |
| Classification per
ASTM D3577 | Type I - gloves compounded primarily
from natural | Same |
6
| Dimensions | Size 6, 6.5, 7, 7.5, 8, 8.5,
Dimensions comply with ASTM D3577 | Similar |
|---------------------|-------------------------------------------------------------------|---------|
| Physical properties | Comply with ASTM D3577 | Same |
| Freedom from Holes | Comply with ASTM D3577
and ASTM D5151 | Same |
| Powder Content | Comply with ASTM D3577
and ASTM D6124 | Same |
| Protein Content | Comply with ASTM D3577
and ASTM D5712 | Same |
| Biocompatibility | Comply with ISO 10993-10 | Same |
| Sterilization | Gamma radiation,SAL:10-6 | Same |
| Label and Labeling | Meet FDA's Requirements | Same |
10.0 Conclusion:
Based on the information summarized above, the subject device, TULIP Natural Rubber Latex Surgeon's Glove (Powdered), is determined to be Substantially Equivalent (SE) to the predicate device, Motex Powder-Free Surgical Gloves & Powdered Latex Surgical Gloves (K063757).