(236 days)
The POWDER FREE patient examination gloves is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
The subject device is a vinyl examination glove made of synthetic poly vinyl chloride compound. It is sterile, POWDER FREE. The device is ambidextrous. The device meets ASTM D 5250-06: Standard specification for poly vinyl chloride gloves for medical application. The device is for over-the counter single use.
The provided document is a 510(k) premarket notification for Sterile Vinyl Examination Gloves, Powder Free by Primus Gloves, Pvt. Limited (K170612). This document is a regulatory submission for a Class I medical device, which typically does not involve studies for AI performance or clinical efficacy comparison in the way a diagnostic imaging device would. Instead, the "acceptance criteria" and "study" refer to demonstrated conformance with established industrial standards for medical gloves and substantial equivalence to a predicate device.
Let's break down the information based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by various ASTM and ISO standards for examination gloves. The reported device performance indicates that the "Sterile Vinyl examination gloves, POWDER FREE" meet these specified standards.
| Characteristics | Standard (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Freedom from Holes | ASTM D 5250-06 / ASTM D5151-06 (FDA 1000 ml water leak test) (AQL 2.5) | Meets (PASS) |
| Dimensions | ASTM D 5250-06 (AQL 4.0) | Meets (Length > 230mm, Width 85±5 mm to 115±5 mm, Thickness finger > 0.05mm & palm > 0.08mm) (PASS) |
| Physical Properties | ASTM D 5250-06 / ASTM D412-06 (AQL 4.0) | Meets (Before & After Aging: Tensile strength > 11 Mpa, Ultimate Elongation > 300%) (PASS) |
| Powder Free Residue | ASTM D 5250-06 / ASTM D6124-06 | Meets (Less than 2 mg per glove) (PASS) |
| Biocompatibility (Irritation) | Primary skin irritation ISO 10993-10 | Non-irritant (PASS) |
| Biocompatibility (Sensitization) | Skin/Dermal Sensitization ISO 10993-10 | Non-sensitizer (PASS) |
| Expiration Dating/Shelf Life | ASTM D7160-05 | Three years |
| Sterility | ISO 11737-02 | Meets (PASS) |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates sampling plans based on ISO 2859-1 for various tests (e.g., G1/AQL 2.5 for freedom from holes, S2/AQL 4.0 for dimensions and physical properties). For Powder Free residue, N=5 is stated.
- Sample Size:
- For physical characteristics (Freedom from Holes, Dimensions, Physical Properties): Specific sample sizes are not explicitly given as absolute numbers, but the reference to ISO 2859-1 with specified Inspection Levels (G1, S2) and AQLs (2.5, 4.0) implies a statistical sampling methodology based on lot size.
- For Powder Free residue: N=5 gloves.
- For biocompatibility: The ISO 10993-10 standards would specify animal testing protocols (e.g., rabbits for irritation, guinea pigs for sensitization), but the exact number of animals or repeat tests is not provided in this summary.
- Data Provenance: Not explicitly stated for each test result, but the manufacturing company is PRIMUS GLOVES PRIVATE LIMITED located in Cochin, Kerala, India. It can be inferred that the testing data was generated locally or through contract labs testing products manufactured at this site. The studies are retrospective in the sense that they are tests performed on manufactured batches to confirm compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (examination gloves) does not typically involve human expert consensus for "ground truth" in the way an AI diagnostic algorithm would. The "ground truth" is defined by adherence to objective, measurable physical, chemical, and biological properties as specified in the referenced ASTM and ISO standards.
- Number of Experts: Not applicable in the context of expert consensus for AI ground truth. The "experts" in this scenario are the technical committees and bodies that establish the ASTM and ISO standards, and the qualified laboratory personnel who conduct the standardized tests.
- Qualifications of Experts: N/A for clinical expert consensus. The "experts" are the technicians and engineers performing standardized tests in accredited laboratories.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI diagnostic device requiring adjudication of interpretations. The tests are objective measurements against established thresholds.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, this is not an AI device or a diagnostic device that would typically undergo an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is a physical medical device (examination gloves), not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on objective, measurable criteria defined by international and national standards and specifications (e.g., ASTM D 5250-06, ASTM D5151-06, ISO 10993-10, ISO 11737-02). These standards define acceptable ranges for physical dimensions, mechanical properties, chemical residue, and biological responses (biocompatibility).
8. The Sample Size for the Training Set
Not applicable. This is a manufactured product, not an AI model that requires a training set. The "training" for such a product would involve process validation and quality control measures during manufacturing, but not a dataset as understood in AI/ML.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of an AI device. The manufacturing processes are validated to consistently produce gloves that meet the defined standards.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo.
October 23, 2017
Primus Gloves, Pvt. Limited Jose Paul M Manager QA & RA Plot No 14-A, Cochin Special Economic Zone, Kakkanad Cochin, 682037 INDIA
Re: K170612
Trade/Device Name: Sterile Vinyl Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 25, 2017 Received: September 28, 2017
Dear Jose Paul M:
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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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,
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
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Indications for Use
510(k) Number (if known) K170612
Device Name STERILE VINYL EXAMINATION GLOVES, POWDER FREE
Indications for Use (Describe)
The POWDER FREE patient examination gloves is a disposable device intended for medical purposes that is worn on the examiners 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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SUBMITTER 1.0
| 1.1 | Company Name | : | PRIMUS GLOVES PRIVATE LIMITED |
|---|---|---|---|
| 1.2 | Address | : | Plot No: 14-A, Cochin Special Economic ZoneKakkanad, Cochin, Kerala, India - 682037 |
| 1.3 | Telephone | : | + 91 484 2413063 |
| 1.4 | Fax | : | +91 484 2413089 |
| 1.5 | : | josepaul@primusgloves.com | |
| 1.6 | Contact Person | : | Mr. JOSE PAUL MMANAGER – QA & RA |
OFFICIAL CORRESPONDENT 2.0
| 2.1 Company Name | PRIMUS GLOVES PRIVATE LIMITED |
|---|---|
| 2.2 Address | Plot No: 14-A, Cochin Special Economic Zone, Kakkanad, Cochin, Kerala, India - 682037 |
| 2.3 Telephone | + 91 484 2413063 |
| 2.4 Fax | +91 484 2413089 |
| 2.5 Email | josepaul@primusgloves.com |
| 2.6 Contact Person | Mr. JOSE PAUL M |
| MANAGER — QA & RA | |
| 3.0 Preparation date | 13th OCTOBER, 2017 |
| 4.0 Name of the device | |
| 4.1 Device Name | STERILE VINYL EXAMINATION GLOVES, POWDER FREE, |
| 4.2 Trade Name | PRIMUS VINYL EXAMINATION GLOVES PF |
| 4.3 Common Name | PATIENT EXAMINATION GLOVES |
| 4.4 Classification | PATIENT EXAMINATION GLOVES |
| 4.5 Class | CLASS I |
| 4.6 Product code | LYZ |
| 4.7 510(K)Number | K 170612 |
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K170612
5.0 Identification of the legally marketed predicate device
| 5.1 | Device Name | POWDER FREE STERILE VINYL EXAMINATIONGLOVE (Clear and Yellow) |
|---|---|---|
| 5.2 | 510(k) Number | K 053523 |
| 5.3 | Company | Shijiazhuang Hongxiang Plastics Products Co LtdC/O Ms. Micky Lin, Gloveco, Inc. 3973 Schaefer Ave.Chino, California 97710 |
| 5.4 | Device Description | POWDER FREE STERILE VINYL EXAMINATIONGLOVES(Clear and Yellow) |
| 5.5 | Classification | PATIENT EXAMINATION GLOVES |
| 5.6 | Class | CLASS I |
| 5.7 | Product code | LYZ |
| 5.8 | Classification Panel | General Hospital |
6.0 Description of the Device
The subject device is a vinyl examination glove made of synthetic poly vinyl chloride compound. It is sterile, POWDER FREE. The device is ambidextrous. The device meets ASTM D 5250-06: Standard specification for poly vinyl chloride gloves for medical application.
The device is for over-the counter single use.
7.0 Indications for use
The POWDER FREE patient examination gloves is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner
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Summary of performance data 8.0
There is no difference in technological characteristics compared to the predicate device. Gloves are made from Poly vinyl chloride compound, sterile, POWDER FREE. The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below,
| Characteristics | Standards | Performance of SterileVinyl examination gloves,POWDER FREE |
|---|---|---|
| Freedom from Holes | ASTM D 5250-06/ ASTMD5151-06 | Meets |
| Dimensions | ASTM D 5250-06 | Meets |
| Physical Properties | ASTM D 5250-06 / ASTMD412-06 | Meets |
| POWDER FREEresidue | ASTM D 5250-06 | Meets |
| Bio-compatibility | Primary skin irritationISO 10993-10Skin/Dermal SensitizationISO 10993-10 | Non-irritantNon-sensitizer |
| Expirationdating/Shelf life | ASTM D7160-05 | Three years |
| Sterility | ISO 11737-02 | Meets |
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Performance data of gloves based on ASTM D 5250-06and FDA 1000ml water leak test
| ASTM D 5250-06and FDA 1000 ml water leak test | |||||
|---|---|---|---|---|---|
| Characteristics | Test | Teststandard | Samplingplan/Inspectionlevel/AQL | sterile, vinylexaminationgloves -PRIMUS | RESULT |
| Freedom fromPin holes | FDA 1000 mlwater leaktest | ASTM D5151-06 (reap2011) | ISO 2859-1 /G1/AQL 2.5 | PASS | PASS |
| Dimensions | Length | ASTM D5250-06 | ISO 2859-1 /S2/AQL 4.0 | > 230 mm | PASS |
| Width | ASTM D5250-06 | ISO 2859-1 /S2/AQL 4.0 | 85±5 mm to115±5 mm (sizes S to XL) | PASS | |
| Thickness | ASTM D5250-06 | ISO 2859-1 /S2/AQL 4.0 | > 0.05 in finger& 0.08 in palm | PASS | |
| Physicalproperties | Before aging | ASTM D5250-06andASTM D412-06 | ISO 2859-1 /S2/AQL 4.0 | Tensilestrength :> 11 MpaUltimateElongation : >300 % | |
| AfterAcceleratedaging | ASTM D5250-06andASTM D412-06 | ISO 2859-1 /S2/AQL 4.0 | Tensilestrength :> 11 MpaUltimateElongation : >300 % | PASS | |
| POWDER FREEresidue | POWDERFREEresidue | ASTM D5250-06andASTM D6124-06 | N=5 | Less than 2 mgper glove | PASS |
| Bio compatibility | Primary skinirritation | ISO 10993-10 | Under the conditions of thestudy the device is not anirritant | PASS | |
| Skin/DermalSensitization | ISO 10993-10 | Under the conditions of thestudy the device is not asensitizer | PASS | ||
| Sterility | ISO 11737-02 | Sterile | Pass |
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Predicate comparison chart 9.0
| Characteristics | PREDICATE – 510(K) :K053523 | SUBJECT DEVICE | Acceptancecriteria/Standard |
|---|---|---|---|
| Manufacturer | Shijiazhuang HongxiangPlastics Products Co LtdC/O Ms. Micky Lin, Gloveco,Inc. 3973 Schaefer Ave.Chino, California 97710 | PRIMUS GLOVES PRIVATELIMITED, Plot No: 14-A,CSEZ, Kakkanad, Cochin,Kerala, India -682037 | |
| Product Name | POWDER FREE STERILEVINYL EXAMINATIONGLOVES(Clear and Yellow) | STERILE VINYLEXAMINTIONGLOVES, POWDER FREE | Similar |
| Intended Use | The patient examinationgloves is a disposable deviceintended for medicalpurposes that is worn on theexaminers hand or finger toprevent contaminationbetween patient andexaminer | The patient examinationgloves is a disposable deviceintended for medicalpurposes that is worn on theexaminers hand or finger toprevent contaminationbetween patient andexaminer | Similar |
| Indication foruse | The patient examinationgloves is a disposable deviceintended for medicalpurposes that is worn on theexaminers hand or finger toprevent contaminationbetween patient andexaminer | The patient examinationgloves is a disposable deviceintended for medicalpurposes that is worn on theexaminers hand or finger toprevent contaminationbetween patient andexaminer | Similar |
| Description | POWDER FREE sterile VinylExamination glove(clear andyellow) is made of poly vinylchloride The gloves areprovided in Sizes Small,Medium, Large and ExtraLarge | sterile Vinyl Examinationgloves POWDER FREE ismade of poly vinyl chlorideThe gloves are provided inSizes Small, Medium, Largeand Extra Large | Similar |
| Presentation | Sterile gloves areprovided in pouches | Sterile gloves areprovided in pouches | Similar |
| Material | Poly Vinyl Chlorid | Poly Vinyl Chlorid | Similar |
| Non-sterile or sterile | Sterile | Sterile | Similar |
| Single Use | Yes | Yes | Similar |
| Ambidextrous | Yes | Yes | Similar |
| Dimensions | Meets ASTM D 5250-06 | Overall length min 230mm ,width varies from80 mm for small sizeto 115 mm for Largesize, thickness infinger 0.05 mm min&,Palm 0.08 mm min | Similar |
| Tensile strength 11Mpa min for before &after agingAging done at 70 ±2deg C for 72±2 hrs | Similar | ||
| Tensile Strength | Meets ASTM D 5250-06 | ||
| Ultimate Elongation | Meets ASTM D 5250-06 | Ultimate elongation300 % min for before& after aging. Agingdone at 70 ±2 deg Cfor 72±2 hrs | Similar |
| Freedom frompinholes | Meets ASTM D 5151 -06 and ASTM D5250-06 | Meets ASTM D 5151 -06 (2011) and ASTMD 5250-06 | Similar |
| Residual Powder | Meets ASTM D 6124-06 | Less than 2 mg perglove | Similar |
| Biocompatibility Tests | Non-irritant -PrimarySkin Irritation InRabbits | Under the conditionsof the study the deviceis not an irritant | Similar |
| ISO 10993-10 | Non-sensitizer - skinSensitization inGuinea pigs | Under the conditionsof the study the deviceis not a sensitizer | |
| Labeling | POWDER FREE,Vinyl ExaminationglovesterileSingle use onlyAmbidextrousManufactured forLot NoIntended useQuantityCountry of origin | POWDER FREE, Vinyl Examinationglove* sterileSingle use only Ambidextrous*Manufactured for*Lot No*Intended use*Quantity*Country of origin | Similar |
| Sterility | Sterile | Sterile | Similar |
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K170612
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CONCLUSION 10.0
Based on the intended use, physical properties and technological characteristics, the subject device is as safe, as effective and performs as well as the legally marketed 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.