(56 days)
Not Found
No
The device is a patient examination glove, and the description focuses on material properties and regulatory standards, with no mention of AI or ML.
No
The device is a patient examination glove, which is intended to prevent contamination between patient and examiner. It is not designed to treat or alleviate a medical condition.
No
Explanation: The device, a patient examination glove, is used to prevent contamination and is not involved in diagnosing medical conditions by detecting, assessing, or monitoring diseases or injuries.
No
The device is a physical examination glove, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for infection control, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and material of the glove, not on any reagents, instruments, or systems used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm- of Glove or Less of Water Extractable Protein), meets all of the requirements of ASTM D3578
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
Not Found
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)
The performance test data that support a determination of substantial equivalence are described above.
Characteristic: Dimensions, Standards: ASTM D 3578-10, Device Performance: Meets
Characteristic: Physical Properties, Standards: ASTM D 3578-10, Device Performance: Meets
Characteristic: Freedom from pin-holes, Standards: ASTM D 5151-11, ASTM D 3578-10, Device Performance: Meets, Meets
Characteristic: Powder Free Residue, Standards: ASTM D 6124-11, ASTM D 3578-10, Device Performance: Meets, Meets
Characteristic: Protein Content, Standards: ASTM D 5712-10, ASTM D 3578-10, Device Performance: Meets, Meets
Characteristic: Biocompatibility, Standards: Dermal Sensitization (as per ISO 10993-10:2010), Device Performance: Not a contact skin sensitizer
Characteristic: Biocompatibility, Standards: Primary Skin Irritation Test (as per ISO 10993-10:2010), Device Performance: Not a primary skin irritant
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
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
K123757
ASSURGUARD SDN. BHD. (Company No.888413-H)
FEB 0 1 2013
FDA 510(k), Premarket Notification : 510(k) Summary of Safety and Effectiveness Information
Date: 01 December 2012
- 1.0 Submitter:
| Name: | ASSURGUARD SDN. BHD. |
|---|---|
| Address: | 82F, Jalan Pulasan, 41000 Klang, Selangor Darul Ehsan, Malaysia. |
| Country: | Malaysia |
| Phone No.: | +603 3297 1020 |
| Fax No.: | +603-3291 3594 |
| Registration No.: | Pending (First Device) |
2.0 Contact Person:
| Contact: | Mr. Lim Hui Guan |
|---|---|
| E-mail: | assurguard@gmail.com |
| Telephone No.: | +603 3297 1020 |
| Fax No.: | +603 3291 3594 |
3.0 Name of Device:
Trade Name:
Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm2 of Glove or Less of Water Extractable Protein), Natural Color Common Name: Patient Examination Glove Classification Name: Patient Examination Glove.
Identification of The Legally Marketed Device: 4.0
Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm2 of Glove or Less of Water Extractable Protein), 80L Y Y, meets all of the requirements of ASTM D3578 Standard Specification for Latex Examination Gloves for Medical Application.
Predicate Device: K112988, Powder Free Latex Patient Exam Glove, Smooth and Textured natural Color (Off White) with Protein Labeling Claim (50 ug/dm² or Less of Water Soluble Protein)
5.0 Description of Device:
Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm- of Glove or Less of Water Extractable Protein), meets all of the requirements of ASTM D3578
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ASSURGUARD SDN. BHD. (Company No.888413-H)
6.0 Intended Use of the Device:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Summary of The Technological Characteristics of The Device: . 7.0
Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm2 of Glove or Less of Water Extractable Protein) possesses the following technological characteristic (as compared to ASTM or equivalent standards):
| Characteristic | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-10 | Meets |
| Physical Properties | ASTM D 3578-10 | Meets |
| Freedom from pin- | ||
| holes | ASTM D 5151-11 | |
| ASTM D 3578-10 | Meets | |
| Meets | ||
| Powder Free Residue | ASTM D 6124-11 | |
| ASTM D 3578-10 | Meets | |
| Meets | ||
| Protein Content | ASTM D 5712-10 | |
| ASTM D 3578-10 | Meets | |
| Meets | ||
| Biocompatibility | Dermal Sensitization | |
| (as per ISO 10993- | ||
| 10:2010) | Not a contact skin sensitizer | |
| Primary Skin | ||
| Irritation Test | ||
| (as per ISO 10993- | ||
| 10:2010) | Not a primary skin irritant |
Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 8.0 .
The performance test data that support a determination of substantial equivalence are described above.
Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0
Clinical data are not needed for market cleared examination gloves.
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ASSURGUARD SDN. BHD. (Company No.888413-H)
10.0 Conclusion
It can be concluded that the Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm2 of Glove or Less of Water Extractable Protein) is safe and effective for use and will perform according to the glove performance standards referenced in Section 7.0 above.
Substantial Equivalence Discussion 11.0
There is no different between the proposed device and the predicate with respect to indications for use and technological characteristics.
The gloves are identical to predicate device with 510(k) K112988.
The substantial equivalence comparison is presented in Table below:-
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ASSURGUARD SDN. BHD. (Company No.888413-I
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| II. Freedom from holes | Meets ASTM D3578 | Same |
|---|---|---|
| II. Dimension | Meets ASTM D3578 | Same |
| V. Physical Properties | Meets ASTM D3578 | Same |
| V. Powder Free Residue | Meets ASTM D3578 | Same |
| VI. Protein Content | Meets ASTM D3578 | Same |
| Single Use | Yes | Same |
| Biocompatibility Test | Passes | |
| i. Primary Skin Irritation Test | ||
| ii. Dermal Sensitization Test | Same | |
| Packaging | Packed in Dispenser Boxes | Same |
| Labeling Claim | With Extractable Protein Content Labeling Claim | Same |
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around it.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2013
Mr. Lim H. Guan Managing Director Assurguard Sdn. Bhd 82F, Jalan Pulasan Klang Selangor, Malaysia 41000
Re: K123757
Trade/Device Name: Powder Free Latex Patient Examination Gloves, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein), Natural Color
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: December 1, 2012 Received: December 7, 2012
Dear Mr. Guan:
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.
6
Page 2 - Mr. Guan
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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
hor.
Keith
Harshfield.
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number (if known): K 123 757
Powder Free Latex Patient Examination Gloves, with Protein Content Device Name: Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein), Natural Color.
Indication For Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Sheila A. Murphey
N: