(204 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.
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive or allergic to the powdered version of the same gloves.
The provided text describes a 510(k) premarket notification for a medical device: "RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR." This document seeks to establish substantial equivalence to a predicate device, rather than proving that the device meets specific performance acceptance criteria through a clinical study in the way an AI/ML device would.
Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of device submission.
Instead, the acceptance criteria are based on established ASTM standards for patient examination gloves, and the "study" is a series of non-clinical bench tests demonstrating the device's technical characteristics meet these standards and are comparable to the predicate device.
Here's the closest representation of the requested information based on the provided text, adapted for a non-AI medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR" are derived from ASTM standards, primarily ASTM D3578-05 and ASTM D5712-99c1. The reported device performance is based on measurements taken on the new device and compared against these standards and the predicate device (K011271).
| Parameter | Acceptance Criteria (ASTM Specifications) | Reported Device Performance (Measured Values) |
|---|---|---|
| Physical Properties | ||
| Length, mm | 230 min. (ASTM D3578-05) | 290mm-305mm |
| Thickness (palm), mm | 0.08 min. (ASTM D3578-05) | 0.20mm-0.24mm |
| Thickness (finger), mm | 0.08 min. (ASTM D3578-05) | 0.23mm-0.26mm |
| Width (size: Small), mm | 80 ± 10 (ASTM D3578-05) | 82 mm – 85 mm |
| Width (size: Medium), mm | 95 ± 10 (ASTM D3578-05) | 89 mm – 94 mm |
| Width (size: Large), mm | 111 ± 10 (ASTM D3578-05) | 103 mm – 105 mm |
| Tensile Strength, Before Aging, Mpa | 18 min. (ASTM D3578-05) | 23.1 Mpa |
| Tensile Strength, After Aging, Mpa | 14 min. (ASTM D3578-05) | 29.6 Mpa |
| Ultimate Elongation, Before Aging, % | 650 min. (ASTM D3578-05) | 770 % |
| Ultimate Elongation, After Aging, % | 500 min. (ASTM D3578-05) | 830 % |
| Chemical Properties | ||
| Water Extractable Protein, µg/gram | 200 µg/glove max. (ASTM D5712-99c1) | 50 µg/glove and below |
| Residual Powder (size M), mg/glove | 2 mg/glove max. (ASTM D3578-05) | 2 mg/glove and below |
| Integrity Tests | ||
| Water Leak Test, Before Aging, AQL | 2.5 (ASTM D3578-05) | 1.5 and below |
| Water Leak Test, After Aging, AQL | 2.5 (ASTM D3578-05) | 2.5 and below |
| Biocompatibility | ||
| Skin Irritation Test | (ASTM F 720-81 implicit) | Passed* |
| Dermal Sensitization Test | (ASTM F 720-81 implicit) | Passed* |
Note: The document states "Passed" for biocompatibility tests, implying compliance with internal acceptance criteria based on the relevant ASTM standard. For these tests, specific numerical limits are not explicitly stated in the table but are inherent to the "Passed" designation. The ASTM F 720-81 standard is referenced for Biocompatibility Test.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size for each specific test (e.g., how many gloves were tested for length, thickness, tensile strength, etc.). However, compliance with ASTM standards typically involves testing a statistically significant number of samples from production lots to ensure consistency and meet specified AQL (Acceptable Quality Level) values for certain tests like the Water Leak Test.
- Data Provenance: The tests were conducted on the "RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR" manufactured by PERUSAHAAN PELINDUNG GETAH (M) SDN BHD in Malaysia. The tests are non-clinical, bench-top measurements of product characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical device involving physical and chemical property testing, not an AI/ML device relying on expert-adjudicated ground truth. The "ground truth" here is the objective measurement of the glove's parameters against established ASTM standards.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication was involved. Test results were objectively measured against predefined limits in ASTM standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This is a physical medical device, not an AI/ML diagnostic or treatment assistance tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance assessment is based on objective measurements of physical and chemical properties against recognized industry standards (ASTM).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a physical medical device and does not involve AI/ML algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set. The device's characteristics are designed and manufactured to meet predefined specifications and then tested against those specifications.
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APR 2 2 2011
Image /page/0/Picture/1 description: The image shows a stylized letter "P" inside of a square. The left side of the "P" is a vertical rectangle filled with a stippled pattern. The curved part of the "P" is solid black with small white dots scattered throughout.
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD any No. 169997-P Lot 110. Lorong Senawang 4/3, Off Jalan Senswang no Inclustrial Estate, 70450 S Negeri Sembilan Darul Khusus, Malaysi Tcl: 60-6-6772781 Fax: 60-6-677
Image /page/0/Picture/3 description: The image shows a circular logo with the letters "LQS" in the center. The text "Quality Assured" is written around the top of the circle, and "ISO 13485:2003" is written around the bottom. Below the circle, the text "Reg. No. 322408 MP23" is written. The logo appears to be a certification mark indicating that the organization meets the requirements of the ISO 13485:2003 standard for quality management systems.
We are an ISO 13485 Cartified Glove Manufacturing Facility - Protection is in Our Name
510(K) SUMMARY
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD Applicant:
Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat Address Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia.
| Phone No. | 60-6-6772781 | Fax No. | 60-6-6772780 |
|---|---|---|---|
| Contact Person | Lim Kwee Shyan | ||
| Date of Summary | 2nd December, 2010 | ||
| Device Information | |||
| Trade Name | RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR | ||
| Common Name | POWDER FREE LATEX EXAMINATION GLOVE BLUE COLOR | ||
| Classification Name | Patient Examination Gloves |
Claim of Equivalence
The device is a class I latex patient examination gloves 21 CFR 880.6250,Patient Examination Glove, 80LYY which is made powder-free by a process of on-line polymer-coating, meets all the requirements of ASTM standard D 3578-05 and is substantially equivalent in safety and effectiveness to the predicate device K011271 Powder Free Latex Examination Glove, Blue Color.
Device Description
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive or allergic to the powdered version of the same gloves.
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Image /page/1/Picture/1 description: The image shows a sign with the letter 'P' on it. The left side of the 'P' is a vertical rectangle filled with a speckled pattern. The curved part of the 'P' is solid black, contrasting with the white background of the sign.
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD
ot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat Senawang Industrial Estate, 70450 Seremba Negeri Sembilan Darul Khusus, Malaysia Tel: 60-6-6772781
Image /page/1/Picture/4 description: The image shows a circular logo with the text "Quality Management" at the top. Inside the circle, there is a stylized design that appears to be an acronym or initials. Below the design, the text "ISO 13485:2003" is visible, indicating compliance with a specific ISO standard. At the bottom, there is a registration number, "Reg. No. 322406 MP23".
We are an ISO 13485 Certified Glove Manufacturing Facility - Protection is in Our Name
Intended Use of Device
A patient examination glove is a disposable device intended for medical purposes A patient examination grove is a disposable device meetible to the more on the examination between patient and examiner.
Technological Characteristics
Technological Characteristics the measured parameters of the gloves (e.g. lengths, thickness, widths, physical properties, protents, etc) as a secondentiality, pinnsyle, powderlengths, "thickness," widths," priysical" properties) "propertibility, pinhole, powderfree and any other requirements.
| Parameter | ASTMSpecifications | StandardReferences | MeasuredValues | PredicateDeviceK011271 |
|---|---|---|---|---|
| Length, mm | 230 min. | ASTM D3578-05 | 290mm-305mm | 290mm min |
| Thickness (palm), mm | 0.08 min. | ASTM D3578-05 | 0.20mm-0.24mm | 0.20mm-0.24mm |
| Thickness (finger), mm | 0.08 min. | ASTM D3578-05 | 0.23mm-0.26mm | 0.23mm-0.25mm |
| Width (size: Small), mm | $80 \pm 10$ | ASTM D3578-05 | 82 mm –85 mm | 82 mm –85 mm |
| Width (size: Medium), mm | $95 \pm 10$ | ASTM D3578-05 | 89 mm –94 mm | 89 mm –94 mm |
| Width (size: Large), mm | $111 \pm 10$ | ASTM D3578-05 | 103 mm –105 mm | 103 mm –105 mm |
| Tensile Strength, Before Aging, Mpa | 18 min. | ASTM D3578-05 | 23.1 Mpa | 18 Mpa min |
| Tensile Strength, After Aging, Mpa | 14 min. | ASTM D3578-05 | 29.6 Mpa | 14 Mpa min |
| Ultimate Elongation, Before Aging, % | 650 min. | ASTM D3578-05 | 770 % | 770 % |
| Ultimate Elongation, After Aging, % | 500 min. | ASTM D3578-05 | 830 % | 850 % |
| Water Extractable Protein, µg/gram | 200 µg/glove max. | ASTM D5712-99c1 | 50 µg/glove and below | 50 µg/glove and below |
| Water Leak Test, Before Aging, AQL | 2.5 | ASTM D3578-05 | 1.5 and below | 1.5 and below |
| Water Leak Test, After Aging, AQL | 2.5 | ASTM D3578-05 | 2.5 and below | 2.5 and below |
| Residual Powder (size M), mg/glove | 2 mg/glove max. | ASTM D3578-05 | 2 mg/glove and below | 2 mg/glove and below |
| Biocompatability Test | ASTM F 720-81 | |||
| Skin Irritation Test | n.a | n.a | Passed* | Passed* |
| Dermal Sensitization Test | n.a | n.a | Passed* | Passed* |
Substantial Equivalence Conclusions.
Supstantial Equivalence Conclusions
Based on the nonclinical test data , we certify that our gloves: Based on the nonclinical test data , we certing and effectively and effectively as the
is as safe, as effective, and performs at least as safely and effectively as the is as safe, as effective, and periorins at least as sanch en a lease Examination
legally marketed predicate device, KO12271 Powder Free Latex Examination
Collination of Canad legally marketed 'predicate' device, 'AUIT271' Forroll' From Wee
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JUN 16 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Lim Kwee Shyan Chief Executive Officer Managing Director Rubbercare Protection Products Sdn Bhd Lot 110 Lorong Senawang 4/3, Off Jalan Senawang Empat Senawang Industrial Estate 70450 Seremban, Negeri Sembilan Darul Khusus MALAYSIA
- Re: K102902
Trade/Device Name: Powder Free Latex Examination Glove, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: April 5, 2011 Received: April 7, 2011
Dear Lim Kwee Shyan:
This letter corrects our substantially equivalent letter of April 22, 2011.
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 (PMA). You may, therefore, market the device, subject to the general coptvols 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.
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.
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Page 2 - Lim Kwee Shyan
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 regencies. 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 reportung (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 Partly 20); 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 patific: ' on" (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.
Anthony O. norton
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 Center for Devices and Radiological Health
Enclosure
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Indications for Use
Prescription Use
510(k) Number (if known): K102902
Device Name: Powder Free Latex Examination Glove, Blue Color
Indications for Use: 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.
AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Elizabeth F. Clauss-Wells
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _ K/02902
§ 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.