(88 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No.
The device, "Orange Non Sterile Powder Free Nitrile Examination Gloves," is intended to prevent contamination and is a Class I medical device, not a therapeutic device. It does not actively treat or ameliorate a disease or condition.
No
The device is described as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner," which indicates it is a barrier device, not one used for diagnosis.
No
The device is a physical product (gloves) and does not involve any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "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 used for protection during physical examination, not a device used to examine specimens from the human body in vitro (outside the body).
- Device Description: The description details the physical characteristics and standards met by the gloves, all related to their function as a protective barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Orange Non Sterile Powder Free Nitrile Examination Gloves 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
Orange Non Sterile Powder Free Nitrile Examination are Class I Patient Examination Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10 and follows the FDA Medical Glove Guidance Manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
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)
Biocompatibility studies were performed on the proposed device. Under the conditions of the study, the proposed device is not a sensitizer, or an 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 28, 2017
Central Medicare Sdn. Bhd. Arivalagan Subramaniam QA/RA Manager PT 2609 - 2620, BT 8, Jalan Changkat Jong Teluk Intan, 36000 My
Re: K172642
Trade/Device Name: Orange Non Sterile Powder Free Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: August 25, 2017 Received: September 1, 2017
Dear Arivalagan Subramaniam:
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.
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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Orange Non Sterile Powder Free Nitrile Examination Gloves
Indications for Use (Describe)
Orange Non Sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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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Section 2 - 510(k) Summary
Date of Summary Prepared: 25th August 2017
1.0 Submitter:
| Name: | Arivalagan Subramaniam
QA/RA Manager |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Address: | Central Medicare Sdn. Bhd.
PT 2609-2620, Batu 8,
Jalan Changkat Jong, 36000 Teluk Intan,
Perak, Malaysia |
| Contact: | Tel: +605-629 0000 Fax: +605-629 0001 |
| 510(k) Submission Prepared by: | Muhammad Abdul Rahman
Regulatory Affairs Officer
Central Medicare Sdn. Bhd. |
2.0 Name of the device:
Orange Non Sterile Powder Free Nitrile Examination Gloves
| Common Names: | Examination Gloves |
|---|---|
| Device Class: | Class I |
| Classification Names: | Patient Examination Gloves (21 CFR 880.6250 product code |
| LZA) | |
| Review Panel: | General Hospital |
3.0 Identification of the Legally Marketed Devicesthat equivalency isclaimed:
| Proposed Device | Predicate Device | Remark | |
|---|---|---|---|
| Sponsor | Central Medicare Sdn. Bhd. | ||
| (as both the sponsor and manufacturer) | Central Medicare Sdn. Bhd. | ||
| (as both the sponsor and manufacturer) | Same | ||
| Trade Name | Orange Non Sterile Powder Free Nitrile | ||
| Examination Gloves | Powder Free Nitrile Examination Gloves, | ||
| Non Sterile, (Blue Colored, Black Colored, | |||
| and White Colored) | Similar | ||
| 510k Number | K143247 | ||
| Product Code | LZA | LZA | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | Same |
4.0 Description of the Device:
Orange Non Sterile Powder Free Nitrile Examination are Class I Patient Examination Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10 and follows the FDA Medical Glove Guidance Manual.
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PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: +605 629 0000 Fax: +605 629 0001
Section 2 - 510(k) Summary
5.0 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 or finqer to prevent contamination between patient and examiner.
6.0 Summary of the Technological Characteristics of the Device:
The proposed and predicate devices all share the same technological characteristics and design by meeting ASTM D6319-10 and following the FDA's Medical Glove Guidance Manual.
The purpose of this submission is to demonstrate that the proposed device is substantially equivalent, to a legally marketed predicate device, K143247, Powder Free Nitrile Examination Gloves, Non Sterile, (Blue Colored, Black Colored, and White Colored). The proposed device will be known as Orange Non Sterile Powder Free Nitrile Examination Glove.
Biocompatibility studies were performed on the proposed device. Under the conditions of the study, the proposed device is not a sensitizer, or an irritant.
The proposed and predicate devices are made of nitrile synthetic latex. The proposed device have similar technological characteristics compared to the predicate devices, as both devices meet ASTM D6319-10 and follow FDA's Medical Glove Guidance Manual.
The technological characteristics and design for the proposed device have been assessed and confirmed that the standard specifications and performance are appropriate for the requirements of a powder free nitrile examination glove.
The following tables are summaries of the technological characteristics of the proposed and predicate devices.
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PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: +605 629 0000 Fax: +605 629 0001
Section 2 - 510(k) Summary
General Comparison Table:
| Proposed Device | Predicate Device | Remark | |
|---|---|---|---|
| Sponsor | Central Medicare Sdn. Bhd. | ||
| (as both the sponsor and manufacturer) | Central Medicare Sdn. Bhd. | ||
| (as both the sponsor and manufacturer) | Same | ||
| Trade Name | Orange Non Sterile Powder Free Nitrile | ||
| Examination Gloves | Powder Free Nitrile Examination Gloves, | ||
| Non Sterile, (Blue Colored, BlackColored, | |||
| and White Colored) | Similar | ||
| 510k Number | K143247 | ||
| Product Code | LZA | LZA | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | Orange Non Sterile Powder Free Nitrile | ||
| Examination Glovesisa disposable device | |||
| intended for medical purposes that is worn | |||
| on the examiner's hands to prevent | |||
| contamination between patient and | |||
| examiner. | Powder Free Nitrile Examination Gloves, | ||
| Non Sterile, (Blue Colored, Black Colored, | |||
| and White Colored) isa disposable device | |||
| intended for medical purposes that is worn | |||
| on the examiner's hands to prevent | |||
| contamination between patient and | |||
| examiner. | Same | ||
| Powder or Powder | |||
| Free | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Orange | Blue, Blackand White | Similar |
| Labeling | |||
| Information | Single-use indication, powder free, device | ||
| name, glove size, quantity, Nitrile | |||
| Examination Gloves, Non Sterile | Single-use indication, powder free, device | ||
| name, glove size, quantity, Nitrile | |||
| Examination Gloves. Non Sterile | Same |
DimensionsTable:
| Proposed Device | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Size | Tolerance | ||||||||
| XS | S | M | L | XL | |||||
| Orange Non Sterile | |||||||||
| Powder Free Nitrile | |||||||||
| Examination Gloves | Length (mm) | minimum 230 | |||||||
| Width (mm) | 70 | 80 | 95 | 110 | 120 | ±0.10 | |||
| Thickness (mm) | |||||||||
| Palm | - | ||||||||
| Finger | - | ||||||||
| Predicate Device | |||||||||
| Size | Tolerance | ||||||||
| Powder Free Nitrile | |||||||||
| Examination Gloves, Non | |||||||||
| Sterile, (Blue Colored, | |||||||||
| Black Colored, and White | |||||||||
| Colored) | XS | S | M | L | XL | Same | |||
| Length (mm) | minimum 230 | ||||||||
| Width (mm) | 70 | 80 | 95 | 110 | 120 | ±0.10 | |||
| Thickness (mm) | |||||||||
| Palm | - | ||||||||
| Finger | - | ||||||||
| Standard Specification | |||||||||
| Size | Tolerance | ||||||||
| ASTM D6319 - 10(2015) | |||||||||
| Standard Specificationfor | |||||||||
| Nitrile Examination | |||||||||
| Gloves for Medical | |||||||||
| Application | XS | S | M | L | XL | ||||
| Length (mm) | minimum 230 | ||||||||
| Width (mm) | 70 | 80 | 95 | 110 | 120 | ±0.10 | |||
| Thickness (mm) | |||||||||
| Palm | - | ||||||||
| Finger | - |
6
PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: +605 629 0000 Fax: +605 629 0001
Section 2 - 510(k) Summary
Performance Comparison Table:
| Item | Proposed Device | Predicate Device | |||
|---|---|---|---|---|---|
| Color | Orange Non Sterile Powder | ||||
| Free Nitrile Examination | |||||
| Gloves | Powder Free Nitrile | ||||
| Examination Gloves, Non | |||||
| Sterile, (Blue Colored, Black | |||||
| Colored, and White Colored) | Remark | ||||
| Color | Orange | Blue, Black and White | Similar | ||
| Physical | |||||
| Properties | Before | ||||
| Aging | Tensile Strength | 15 Mpa min | 15 Mpa min | Same | |
| Ultimate Elongation | 500% min | 500% min | Same | ||
| After | |||||
| Aging | Tensile Strength | 14 Mpa min | 14 Mpa min | Same | |
| Ultimate Elongation | 400% min | 400% min | Same | ||
| Freedom from Holes | h accordance with ASTM | ||||
| D5151-06, following ASTM | |||||
| D6319 AQL 2.5/Inspection | |||||
| Level G-I | h accordance with ASTM | ||||
| D5151-06, following ASTM | |||||
| D6319 AQL 2.5/Inspection | |||||
| Level G-I | Similar | ||||
| Powder Content | Max. 0.50 mg per glove | Max. 0.40 mg per glove | Similar |
Biocompatibility and Labeling:
| Item | Proposed Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Orange Non Sterile Powder Free | ||||
| Nitrile Examination Gloves | Powder Free Nitrile Examination | |||
| Gloves, Non Sterile, (Blue Colored, | ||||
| Black Colored, and White Colored) | ||||
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation | Under the conditions of the study, | ||
| not an irritant | Under the conditions of the study, | |||
| not an irritant | Same | |||
| Sensitization | Under the conditions of the study, | |||
| not a sensitizer | Under the conditions of the study, | |||
| not a sensitizer | Same | |||
| Labeling | Meet FDA's Recommendations | Meet FDA's Recommendations | Same |
7.0 Substantial Equivalence Based on Assessment of Non-Clinical Performance Data
The proposed device and it's predicate device share intended use, are made of the same material, are within the same minimum specifications of thickness and length by meeting ASTM D6319-10, similar labeling, physical properties, freedom from powder, biocompatibility and water tightness.
The above test results demonstrated that the proposed device complies with the following specification and guidance:
ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application
7
PT 2609 - 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: +605 629 0000 Fax: +605 629 0001
Section 2 - 510(k) Summary
Guidance for Industry and FDA Staff Medical Glove Guidance Manual (Document issued on January 22, 2008)
The following standards were followed to carry out the testing: 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.
ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
ASTM D573 - 04 Standard Test Method for Rubber—Deterioration in an Air Oven ISO 10993-10:2010 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
16 CFR 1500.41 - Method of testing primary irritant substances
8.0 Substantial Equivalence Based on Assessment of Clinical Performance Data
Clinical data is not necessary for Class I Patient Examination Glove 510(k) Submissions.
9.0 Conclusion
Based on intended uses, technological characteristics and non-clinical performance data, the proposed device is substantially equivalent to the predicate device Powder Free Nitrile Examination Gloves, Non Sterile, (Blue Colored, and White Colored) (K143247).