(52 days)
Not Found
No
The device is a patient examination glove, and the description focuses on material properties and standards met, with no mention of AI or ML.
No.
The device, a patient examination glove, is intended to prevent contamination between the patient and examiner, not to treat or diagnose a disease or condition. It is a barrier device for medical purposes.
No
Explanation: The device is a patient examination glove, which is used for contamination prevention during examinations. Its purpose is not to diagnose any condition, but rather to serve as a barrier. The document also states that "Clinical data are not needed for market cleared examination gloves," indicating it's not a diagnostic tool requiring such data for performance evaluation.
No
The device is a physical patient examination glove, not a software application. The description clearly states it is a disposable device worn on the hand.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove... worn on the examiner's hand to prevent contamination between patient and examiner." This describes a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material (nitrile), color, and sterility, and mentions meeting an ASTM standard for examination gloves. This aligns with a physical barrier device.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Any reagents, assays, or analytical procedures
The device is a medical device, specifically a Class I or Class II medical device (depending on the specific regulations and risk classification), but it falls under the category of a physical barrier for infection control, not an in vitro diagnostic.
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)
LZA
Device Description
Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile meet all the current specification for ASTM D6319.
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. Clinical data are not needed for market cleared examination gloves.
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
ASSURGUARD SDN. BHD. (Company No.888413-H)
FDA 510(k), Premarket Notification : 510(k) Summary of Safety and Effectiveness Information
Date: 16 January 2013
1.0 Submitter:
JAN 2 8 2013
| 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 Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored). Non-Sterile. |
|---|---|
| Common Name: | Patient Examination Glove |
| Classification Name: | Patient Examination Glove. |
Identification of The Legally Marketed Device: 4.0
The Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile, Class I Patient Examination gloves, 80LZA, meets all of the requirements of ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application.
.
Predicate Device: K121464, Blue Powder Free Nitrile Patient Exam Glove
5.0 Description of Device:
Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile meet all the current specification for ASTM D6319.
1
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 Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile, possesses the following technological characteristic (as compared to ASTM or equivalent standards):
| Characteristic | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pin- | ||
| holes | ASTM D 5151-11 | |
| ASTM D 6319-10 | Meets | |
| Meets | ||
| Powder Free Residue | ASTM D 6124-11 | |
| ASTM D 6319-10 | Meets | |
| Meets | ||
| Biocompatibility | Dermal Sensitization | |
| (as per ISO 10993- | ||
| 10:2010) | Not a contact skin sensitizer | |
| Primary Skin | ||
| Irritation Test | ||
| (as per 16 CFR Part |
- | Not a primary skin irritant |
8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
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.
2
ASSURGUARD SDN. BHD. (Company No.888413-H)
10.0 Conclusion
It can be concluded that the Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile is safe and effective for use and will perform according to the glove performance standards referenced in Section 7.0 above.
11.0 Substantial Equivalence Discussion
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) K121464.
The substantial equivalence comparison is presented in Table below:-
3
ASSURGUARD SDN. BHD. (Company No.888413-H
Section 11.0 Substantial Equivalence Compariso
| Characteristics | Predicate Device
K121464, Blue Powder Free Nitrile Patient Exam Glove | Proposed Device
Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored). Non-Sterile. |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Product Code | 80 LZA | Same |
| FDA Device Class | Class I | Same |
| Intended Use | Intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | Same |
| 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. | Same |
| Construction | Ambidextrous, Powder Free, Blue, per ASTM D6319 specification. | Ambidextrous, Powder Free, Blue and White, per ASTM D6319 specification. |
| Materials | Nitrile Butadiene Rubber | Same |
| Performance
I. Sterility
II. Freedom from holes
III. Dimension | Non-Sterile
Meets ASTM D6319
Meets ASTM D6319 | Same
Same
Same |
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ASSURGUARD SDN. BHD. (Company No.888413-H
| V. | ||
|---|---|---|
| Physical | ||
| Properties | Meets ASTM D6319 | Same |
| V. Powder Free | ||
| Residue | Meets ASTM D6319 | Same |
| Single Use | Yes | Same |
| Biocompatibility Test | Passes | |
| i. Primary Skin Irritation Test | ||
| ii. Dermal Sensitization Test | Same | |
| Packaging | Packed in Dispenser Boxes | Same |
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
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
January 28, 2013
Mr. Lim Hui Guan Managing Director Assurguard Sdn. Bhd. 82F, Jalan Pulasan Selangor Darul Ehsan Malaysia 41000
Re: K123760
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored). Non-Sterile
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA 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
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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,
Anthong Lo mia
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 \23 760
Powder Free Nitrile Patient Examination Gloves, Blue Colored and Device Name: White (Non-Colored). Non-Sterile
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)
Elizabeth F. Claverie 2013.01.22 18:10:26 -05'00'
K/23760
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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