(227 days)
The device is a disposable patient examination glove made of synthetic rubber intended for medical purposes. It is donned by the user as protection against possible contamination when examining a patient.
Powderfree Chloroprene Flavored and Colored Patient Examination Gloves
The provided text is a 510(k) premarket notification approval letter for "Powder-Free Colored (White, Pink, Blue Green) and Flavored (Strawberry, Tutti-Fruity and Peppermint) Chloroprene Patient Examination Glove." This document is related to the regulatory approval of a medical device, specifically a patient examination glove.
Medical gloves are designed to prevent contamination and act as a barrier. Their performance is primarily evaluated based on their physical integrity (e.g., freedom from holes) and barrier properties. The provided document does not contain specific acceptance criteria for device performance or the details of a study proving those criteria are met.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which means its safety and effectiveness are considered comparable. For devices like gloves, "performance" typically refers to physical properties that ensure their barrier function.
However, based on general knowledge of glove regulatory requirements and what would be typical for a 510(k) submission for such a device, I can infer the types of acceptance criteria and studies that would likely have been submitted.
Inferred Acceptance Criteria and Study (Based on common glove standards and 510(k) requirements):
1. Table of Acceptance Criteria and Reported Device Performance (Inferred):
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Example) | Reported Device Performance (Example - Hypothetical) |
|---|---|---|---|
| Physical Integrity | AQL for Pinholes (e.g., per ASTM D5151 or EN 455-1) | AQL 2.5% or 4.0% (depending on specific standard and glove type, e.g., examination vs. surgical) | Tested at AQL 2.5% with 0.9% detected pinholes |
| Physical Properties | Tensile Strength (e.g., per ASTM D412 or EN 455-2) | Before aging: ≥ 18 MPa; After aging: ≥ 16 MPa (for chloroprene) | Before aging: 23 MPa; After aging: 20 MPa |
| Elongation at Break (e.g., per ASTM D412 or EN 455-2) | Before aging: ≥ 650%; After aging: ≥ 500% (for chloroprene) | Before aging: 720%; After aging: 610% | |
| Biocompatibility | Dermal Sensitization (e.g., per ISO 10993-10) | No or negligible sensitization potential (primary dermal irritation, allergic contact dermatitis) | Passed (no sensitization observed in guinea pig maximization test or human patch test) |
| Cytotoxicity (e.g., per ISO 10993-5) | Non-cytotoxic | Passed (no cytotoxic effect observed in MEM elution test) | |
| Chemical Residues | Powder Residue (for powder-free gloves, per ASTM D6124) | ≤ 2 mg/glove | 1.2 mg/glove |
| Protein Content (for latex, but chloroprene is synthetic) | N/A (chloroprene is synthetic, so protein allergy is not a concern) | N/A | |
| Dimensions | Length, Palm Width, Thickness (e.g., per ASTM D3578 or EN 455-2) | Within specified ranges for each size | All sizes met specified dimensions |
2. Sample Size Used for the Test Set and Data Provenance (Inferred):
- Sample Size: For AQL testing (e.g., pinholes), sample sizes are typically determined by statistical sampling plans, often involving hundreds or thousands of gloves from specific production lots. For physical property tests, smaller but statistically significant sample sizes (e.g., 5-10 gloves per lot) are common. Biocompatibility studies use animal models (e.g., 5-10 animals per test group) or in vitro cell cultures.
- Data Provenance: Likely retrospective (tests performed on manufactured lots) and conducted by the manufacturer (PT Irama Dinamika Latex in Indonesia) or a contracted testing laboratory. The document explicitly states the manufacturer is from Indonesia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts (Inferred):
- For physical and chemical tests of gloves, "ground truth" is typically established by standardized laboratory testing procedures performed by certified technicians or engineers in quality control or R&D departments. There isn't typically an "expert consensus" for these types of objective measurements in the same way there would be for image interpretation in radiology. The "experts" are the personnel competent in performing the specified ASTM or EN standard test methods. Their qualifications include training and experience in metrology, materials science, or chemical analysis, often with documented proficiency in the specific test standards.
4. Adjudication Method for the Test Set (Inferred):
- For objective physical, chemical, and biological tests, adjudication is not typically required in the sense of multiple reviewers resolving discrepancies in subjective interpretations. Instead, results are obtained by following a clearly defined standard. If a result is borderline or unexpected, the test may be repeated by the same or different qualified personnel following the same standard, and statistical methods (e.g., for AQL) would determine acceptance or rejection of a lot.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done (Not Applicable):
- No, an MRMC study would not have been done for a patient examination glove. MRMC studies are used for diagnostic devices (e.g., imaging software) to compare the performance of human readers with and without AI assistance on complex cases. A glove is a physical barrier device, not a diagnostic tool requiring human interpretation of information.
6. If a Standalone Study (Algorithm Only) was Done (Not Applicable):
- No, a "standalone" study is not applicable for this device. This refers to the performance of an AI algorithm without human input. A glove is a physical product; there is no embedded algorithm.
7. The Type of Ground Truth Used (Inferred):
- Objective Measurement Data based on Recognized Standards:
- For physical integrity (pinholes): Determined by water leak test or air inflation test as per ASTM D5151 or EN 455-1.
- For physical properties (tensile strength, elongation): Determined by mechanical testing equipment as per ASTM D412 or EN 455-2.
- For biocompatibility: Determined by in vitro (cytotoxicity) and in vivo (sensitization) tests following ISO 10993 series.
- For chemical residues: Determined by gravimetric or analytical chemistry methods (e.g., for powder residue via ASTM D6124).
8. The Sample Size for the Training Set (Not Applicable):
- Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established (Not Applicable):
- Not applicable. As there is no training set for an algorithm, this question is not relevant.
Summary of Device and Approval:
The provided document details the FDA's approval of "Powder-Free Colored and Flavored Chloroprene Patient Examination Gloves" for marketing based on their substantial equivalence to predicate devices. This means that the device is considered safe and effective because it performs at least as well as other legally marketed gloves, likely demonstrated through a battery of standard physical, chemical, and biological tests. However, the specific test results and acceptance criteria are not included in this regulatory letter itself, but would have been part of the manufacturer's 510(k) submission.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1998 NOV
Mr. Anil Taneja General Manger Pt. Irama Dinamika Latex Jl. Kapten Pattimura No. 23/235 Medan 20153 INDONESIA
Re: K981064 Trade Name: Powder-Free Colored (White, Pink, Blue Green) and Flavored (Strawberry, Tutti-Fruity and Peppermint) Chloroprene Patient Examination Glove Regulatory Class: I Product Code: LZA September 28, 1998 Dated: October 1, 1998 Received:
Dear Mr. Taneja:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Taneja
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours, Susas Kursan Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K#981064
PT. IRAMA DINAMIKA LATEX Jl. Kapten Pattimura No. 23 / 235, Medan - 20153,Indonesia PHONE : (62-061) 515-834; 576-502; FAX: 553-389 e-mail : ptirama@indosat.net.id
ATTACHMENT # 1
INDICATION FOR USE
| Applicant | : PT Irama Dinamika Latex |
|---|---|
| Device | : Powderfree Chloroprene Flavored and Colored Patient Examination Gloves |
| Indication for use: | The device is a disposable patient examination glove made of syntheticrubber intended for medical purposes. It is donned by the user asprotection against possible contamination when examining a patient. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_ X
(Optional Format 1-2-96)
6
§ 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.