(102 days)
Not Found
No
The device description and performance metrics are focused on the physical properties and safety of examination gloves, 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 in a patient.
No
Explanation: The device is a patient examination glove, described as a barrier to prevent contamination between patient and examiner. Its functions are related to physical properties, barrier integrity, and biocompatibility, not to diagnosing medical conditions.
No
The device description clearly states it is a physical glove, not software.
No, 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 device used for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and standards (ASTM D6319) of a glove.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information
- Using reagents or assays
The information provided describes a Class I medical device (examination glove) used for barrier protection.
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
LZA
Device Description
Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile will 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
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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 device was evaluated for Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, and Biocompatibility (Dermal Sensitization and Primary Skin Irritation Test).
Key results: The device meets the standards for all evaluated characteristics.
- Dimensions: ASTM D 6319 – 00a (2005) - Meets
- Physical Properties: ASTM D 6319 – 00a (2005) - Meets
- Freedom from pin-holes: ASTM D 5151 – 99 (2006) and ASTM D 6319 – 00a (2005) - Meets
- Powder Free Residue: ASTM D 6124 – 06 and ASTM D 6319 – 00a (2005) - Meets
- Biocompatibility: Dermal Sensitization (as per ASTM F720-81) - Not a contact skin sensitizer; Primary Skin Irritation Test (as per 16CFR Part1500) - Not a primary skin irritant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FDA 510(k), Premarket Notification : 510(k) Summary of Safety and Effectiveness Information
Date: 12 February 2011
1.0 Submitter:
IDEAL QUALITY SDN. BHD. Lot 2796, 17 1/2 Miles, Jalan Kapar, 42200 Klang, Selangor Darul Ehsan, Malaysia.
Telephone No.: +603 3291 0516 Fax No.: +603 3291 0584
2.0 Contact Person:
| Contact: | Mr. SH TAN |
|---|---|
| E-mail: | shtan@ideal-quality.com |
| Telephone No.: | +603 3291 0516 |
| Fax No.: | +603 3291 0584 |
3.0 Name of Device:
| Trade Name: | Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non-Sterile |
|---|---|
| Common Name: | Patient Examination Glove |
| Classification Name: | Patient Examination Glove. |
4.0 Identification of The Legally Marketed Device:
The Powder Free Nitrile Examination Gloves, White (non colored) or Blue (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: K060771, Powder Free Nitrile Examination Glove, White (Non-Colored) and Blue Colored
5.0 Description of Device:
Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile will meet all the current specification for ASTM D6319.
1
IDEAL QUALITY SDN. BHD. (Company No.404964-P)
6.0 Intended Use of the Device:
Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored). Non-Sterile.
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.
7.0 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.
8.0 Summary of The Technological Characteristics of The Device:
Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile possesses the following technological characteristic (as compared to ASTM or equivalent standards):
| Characteristic | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319 – 00a | |
| (2005) | Meets | |
| Physical Properties | ASTM D 6319 – 00a | |
| (2005) | Meets | |
| Freedom from pin-holes | ASTM D 5151 – 99 (2006) | |
| ASTM D 6319 – 00a | ||
| (2005) | Meets | |
| Meets | ||
| Powder Free Residue | ASTM D 6124 – 06 | |
| ASTM D 6319 – 00a | ||
| (2005) | Meets | |
| Meets | ||
| Biocompatibility | Dermal Sensitization | |
| (as per ASTM F720-81) |
Primary Skin Irritation Test
(as per 16CFR Part1500) | Not a contact skin sensitizer
Not a primary skin irritant |
Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 9.0
The performance test data that support a determination of substantial equivalence are described above.
Lot 2796, 17 ½ Mile, Jalan Kapar, 42200 Klang, Selangor, Malaysia Tel: 603-3291 0516, Fax: 603-3291 0584
2
IDEAL QUALITY SDN. BHD. (Company No.404964-P)
Substantial Equivalent Based on Assessment of Clinical Performance Data 10.0
Clinical data are not needed for market cleared examination gloves.
11.0 Conclusion
It can be concluded that the Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored) or, Non Sterile is safe and effective for use and will perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product.
Consequently, this device is substantially equivalent to current marketed devices.
This summary will include any other information reasonably deemed necessary by the FDA.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. SH TAN Quality Assurance Manager IDEAL QUALITY SDN. BHD. Lot 2796, 17 1/2 Miles Jalan Kapar, 42200 Klang, Selangor Darul Ehsan. Malaysia
FEB 2 5 231
Re: K103337
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: February 12, 2011 Received: February 16, 2011
Dear Mr. TAN:
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 Eederal Register.
4
Page 2- Mr. TAN
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Susan Bauer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and dental Devices Office of Device Evaluation
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Powder Free Nitrile Patient Examination Gloves, Blue Colored and Device Name: White (Non-Colored). Non-Sterile
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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
x 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)
Eby, Wit H. Clavine-Will
ision of Anesthesiology, General Hospit ision Control, Dentrol, Devices i
510(k) Number