(95 days)
A 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
Non-Sterile, Powder Free Nitrile Examination Gloves - Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for overthe counter single use.
The provided document is a 510(k) premarket notification for a medical device: "Powder Free Nitrile Examination Glove". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials or a specific study designed to meet detailed acceptance criteria typical of novel AI/ML devices. Therefore, the questions related to AI/ML device studies (such as MRMC studies, ground truth establishment for AI training/test sets, effect sizes of AI assistance, and number of experts for ground truth) are not applicable to this document.
For this conventional medical device, the "acceptance criteria" are essentially the performance standards outlined in ASTM Specification D6319-10 and other relevant tests for patient examination gloves. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted by the manufacturer.
Here's an interpretation of the document in the context of the requested information, noting the inapplicable fields:
Acceptance Criteria and Device Performance for Powder Free Nitrile Examination Glove (K171667)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on ASTM Specification D6319-10. The performance data for the subject device (K171667) is compared to these ASTM standards (or implied standards based on the predicate device's specifications).
| Characteristics and Parameters | Acceptance Criteria (from ASTM/Predicate) | Reported Device Performance (K171667) | Comparison/Status |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Intended Use | Prevention of contamination between patient and examiner | Prevention of contamination between patient and examiner | Same |
| Classification | Class I | Class I | Same |
| Raw Rubber Material | Nitrile (Acrylonitrile-butadiene) | Nitrile (Acrylonitrile-butadiene) | Same |
| Surface Appearance | Blue, Ambidextrous, Finger Textured | Blue, Ambidextrous, Finger Textured | Similar |
| Overall Length Minimum | 230mm | Average: 242 mm | Meets/Similar |
| Width (S, M, L) | S: 75-95mm, M: 85-105mm, L:100-120mm | S: 85mm, M: 95mm, L: 104mm | Meets/Similar |
| Palm Thickness (Minimum) | 0.05mm | Average: 0.06mm | Meets/Similar |
| Finger Thickness (Minimum) | 0.05mm | Average: 0.07mm | Meets/Similar |
| Tensile Strength (before age) | Minimum 14 MPa | Average: 17.44 MPa | Meets/Similar |
| Tensile Strength (After Age) | Minimum 14 MPa | Average: 16.37 MPa | Meets/Similar |
| Ultimate Elongation (before age) | Minimum 500% | Average: 559% | Meets/Similar |
| Ultimate Elongation (after age) | Minimum 400% | Average: 508% | Meets/Similar |
| Freedom of Holes | Meet AQL 2.5 at G1 | Meet AQL 1.5 with G1 | Meets/Same (better) |
| Residual powder test (per glove) | Less than 2mg/glove | S: 0.43 mg/glove, M: 0.31 mg/glove, L: 0.47 mg/glove | Meets/Similar |
| Primary Skin Irritation | Not an irritant (under study conditions) | Not an irritant | Same |
| Dermal Sensitization | Not a sensitizer (under study conditions) | Not a sensitizer | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for Freedom of Holes, tensile strength, etc.). However, it indicates that the tests conform to ASTM standards (e.g., ASTM Specification D6319-10), which would prescribe appropriate sample sizes for such physical and chemical tests.
- Data Provenance: The manufacturer, Professional Latex Sdn Bhd, is based in Malaysia ("Kamunting, Perak"). The testing would have been conducted by or for the manufacturer. The data is retrospective in the sense that the tests were performed and results collected before the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as this is a physical medical device (examination gloves), not an AI/ML diagnostic or image analysis device that requires expert human interpretation for "ground truth". The "ground truth" for these tests are the objective measurements (e.g., tensile strength, dimensions, water leak test results).
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert review processes for subjective assessments (e.g., image interpretation), which is not relevant for the objective physical and chemical tests of gloves.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. This is not an AI/ML device, and no MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on objective physical, chemical, and biological test measurements as per recognized standards (e.g., ASTM D6319-10). Examples include:
- Physical measurements: Length, width, thickness (using calipers/micrometers).
- Mechanical properties: Tensile strength, ultimate elongation (using a universal testing machine).
- Barrier integrity: Freedom of holes (water leak test, AQL).
- Chemical analysis: Residual powder (gravimetric analysis).
- Biocompatibility: Primary skin irritation, dermal sensitization (in vivo animal or in vitro tests).
8. The Sample Size for the Training Set
This question is not applicable. This is not an AI/ML device, so there is no "training set." The glove manufacturing process involves quality control and testing of product batches.
9. How the Ground Truth for the Training Set was Established
This question is not applicable. As there is no "training set" in the AI/ML sense, this process is irrelevant for this device.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2017
Professional Latex Sdn Bhd Mr. Terence Lim Regulatory Affairs Manager Lot 52. Jalan Logam 2. Kamunting Raya Industrial Kamunting, 34600 MY
Re: K171667
Trade/Device Name: Powder Free Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: August 10, 2017 Received: August 10, 2017
Dear Mr. Terence Lim:
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 (reporting of medical device
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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 contact the Division of Industry and Consumer Education (DICE) 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 (DICE) 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,
Lori A. Wiggins -S6
Lori A. Wiggins, MPT, CLT Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Powder Free Nitrile Examination Glove
Indications for Use (Describe)
A 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
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k)#: K171667
510 (K) SUMMARY
- 2.0 Submitter
1.0
Professional Latex Sdn Bhd Lot 52, Jalan Logam 2, Kamunting Raya Industrial 34600 Kamunting, Perak
| Tel: | +605 - 891 1637 |
|---|---|
| Fax: | +605 - 891 1417 |
| Name of Contact Person: | Terence Lim |
| Email Address: | Terencelim @professionallatex.com |
| Date of Summary Prepared: | September 3, 2017 |
3.0 Name of Device:
| Trade Name: | Powder Free Nitrile Examination Glove |
|---|---|
| Classification Name: | Polymer Patient Examination Glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LZA |
4.0 Identification of The Legally Marketed Device
Predicate Device Name: RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
Predicate 510(K) Number: K100603
Manufacturer's Name: Riverstone Resources Sdn Bhd Jalan Jasmin 2 48300 Bukit Beruntung
5.0 Description of Device
Non-Sterile, Powder Free Nitrile Examination Gloves - Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for overthe counter single use.
6.0 The Intended Use of Glove
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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- 7.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for Substantial Equivalent Discussion.
There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Nitrile Examination Gloves, Blue, has the below technological characteristic compared to ASTM or Equivalent standards.
| Characteristicsand Parameters | Powder Free NitrileExamination Gloves(K171667) | Powder Free NitrileExamination Gloves(K100603) | Comparison |
|---|---|---|---|
| Product Code | LZA | LZA | Same productCode |
| Intended Use | A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the hand orfinger to preventcontamination betweenpatient and examiner. | A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the hand orfinger to preventcontamination betweenpatient and examiner. | Same IntendedUse |
| Classification | Class I | Class I | Same |
| Raw RubberMaterial | Nitrile (Acrylonitrile-butadiene) | Nitrile (Acrylonitrile-butadiene) | Same |
| SurfaceAppearance | 1.Blue2. Ambidextrous3.Finger Textured | 1.Blue2. Ambidextrous3.Finger Textured | Similar |
| Overall LengthMinimum 230mm | Average: 242 mm | 240 – 250 mm(specification sheet) | Similar |
| WidthS : 75mm - 95mmM: 85mm - 105mmL:100mm - 120mm | Average:S: 85mmM: 95mmL: 104mm | S : 83 - 86 mmM : 93 - 96 mmL : 102 - 105 mm(specification Sheet) | Similar |
| Palm Thickness(Minimum 0.05mm) | Average:0.06mm | 0.07 - 0.09 mm(specification sheet) | Similar |
| Characteristics andParameters | Powder Free NitrileExamination Gloves(K171667) | Powder Free NitrileExaminationGloves (K100603) | Comparison |
| Finger Thickness(Minimum 0.05mm) | Average: 0.07mm | 0.10 - 0.13 mm(specification sheet) | Similar |
| Tensile Strength(before age)Minimum 14 MPa | Average: 17.44 MPa | More than 17 MPa(Specification Sheet) | Similar |
| Tensile Strength(After Age)Minimum 14 MPa | Average: 16.37 MPa | More than 16 MPa(Specification Sheet) | Similar |
| Ultimate Elongationbefore age(Minimum 500%) | Average: 559% | 500% - 600%(Specification Sheet) | Similar |
| Ultimate Elongationafter age(Minimum 400%) | Average: 508% | 400% - 500%(Specification Sheet) | Similar |
| Freedom of HolesMeet AQL 2.5 at G1 | Meet AQL 1.5 with G1 | Meet AQL 1.5 withG1. | Same |
| Residual powder test(Less than2mg/glove) | Average powderresidue for each size:S: 0.43 mg/gloveM: 0.31 mg/gloveL: 0.47 mg/glove | Contained less than2mg/glove | Similar |
| Primary SkinIrritation | Under the conditionsof study, not anirritant | Under the conditionsof study, not anirritant | Same |
| Dermal Sensitization | Under the conditionsof study, not asensitizer | Under the conditionsof study, not asensitizer. | Same |
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Professional Latex Sdn Bhd
Lot 52, Jalan Logam 2, Kamunting Raya Industrial, 34600 Kamunting, Perak
8.0 Non-Clinical Performance Data
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).
9.0 Clinical Performance Data
Not applicable - Clinical data is not needed for gloves
- 10.0 Conclusion
Powder Free Nitrile Patient Examination Glove, Non-Sterile is as safe and as effective and substantially equivalent to the predicate device.
§ 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.