(187 days)
A sterile power-free latex surgeon's glove is a disposable device intended for medical purpose that is worn by operating room personnel to protect a surgical wound from contamination.
Sterile Powder-Free Latex Surgical Gloves
Analysis of Device Acceptance Criteria and Study:
The provided documents are a 510(k) clearance letter from the FDA for "Sterile Powder-Free Latex Surgical Gloves" and related forms. This type of FDA clearance relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical studies with specific acceptance criteria in the way a novel AI or diagnostic device would.
Therefore, many of the requested categories for a study that "proves the device meets the acceptance criteria" are not directly applicable to a 510(k) submission for a Class I medical device like surgical gloves. The "acceptance criteria" here are primarily regulatory and performance standards for gloves, not diagnostic metrics.
However, I can extract information relevant to the intent of your questions based on what is typically required for a 510(k) of this nature.
1. Table of Acceptance Criteria and Reported Device Performance:
For surgical gloves, the primary performance criteria revolve around safety, barrier integrity, and physical properties. These are typically assessed against recognized industry standards (e.g., ASTM, ISO). The 510(k) summary (which is not fully provided here but would be part of the submission) would detail the specific tests conducted and their compliance.
| Acceptance Criteria (Typical for Surgical Gloves) | Reported Device Performance (Inferred/Expected) |
|---|---|
| Pinhole Rating (AQL): < 2.5 (e.g., ASTM D3577) | Met or exceeded AQL standards |
| Tensile Strength: Min. 17 MPa (e.g., ASTM D3577) | Met or exceeded minimum requirements |
| Elongation at Break: Min. 650% (e.g., ASTM D3577) | Met or exceeded minimum requirements |
| Powder Residue: Max 2 mg per glove (if powder-free) | Less than 2 mg per glove |
| Protein Content: < 50 ug/dm² (for latex, if specified) | Met specified protein content limits |
| Sterility Assurance Level (SAL): 10⁻⁶ | Validated sterilization process achieved SAL 10⁻⁶ |
| Biocompatibility: ISO 10993 compliance (e.g., cytotoxicity, sensitization) | Passed biocompatibility tests |
Note: The provided documents do not explicitly state these specific performance metrics or acceptance criteria. They only indicate that the device was found "substantially equivalent" to a predicate device, implying that it meets the performance standards required for such a device. This typically involves performance bench testing.
2. Sample Size Used for the Test Set and Data Provenance:
For surgical gloves, the "test set" would refer to the samples used for physical, chemical, and biological testing.
- Sample Size: Varies depending on the specific test and statistical sampling plan (e.g., AQL tables for pinholes, individual glove samples for tensile strength). These details are not in the provided documents.
- Data Provenance: The testing would typically be performed by the manufacturer (Pamitex Industries Sdn. Bhd.) or a certified testing laboratory, likely in Malaysia (country of origin of the manufacturer). The data would be prospective in the sense that new gloves from production batches are tested for compliance.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This concept is not directly applicable to the 510(k) clearance for surgical gloves. "Ground truth" in this context would be established by objective measurements against recognized standards, not expert consensus on diagnostic images or clinical outcomes. The "experts" would be the engineers and scientists performing the tests according to standardized protocols and interpreting the results against established specifications.
4. Adjudication Method for the Test Set:
Not applicable in the sense of clinical adjudication. Test results for gloves are typically objective measurements (e.g., tensile strength values, pinhole counts) compared against a pre-defined pass/fail criterion. There isn't typically an adjudication process among multiple "experts" for these types of bench tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a diagnostic device where human readers interact with AI.
6. Standalone Performance (Algorithm Only):
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for surgical gloves is based on:
- Objective Measurement against Standards: Performance metrics (e.g., tensile strength, elongation, pinhole rates) are measured directly using standardized testing methods (e.g., ASTM D3577, ISO 11193) and compared to established thresholds.
- Biological Testing: Biocompatibility tests (e.g., ISO 10993 series) evaluate the device's interaction with the body.
- Sterility Testing: Validation of the sterilization process to achieve a specified Sterility Assurance Level (SAL).
8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How Ground Truth for the Training Set Was Established:
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2000
Mr. Said Awang Product Development & Technical QA Pamitex Industries Sdn. Bhd. Batu 2½, Jalan Rasah 70300 Seremban, Negeri Sembilan Darul Khusus MALAYSIA
каяз201 Re : Health-Plus, Sanitex, Reliance Powder-Free Trade Name: Sterile Latex Surgical Gloves Regulatory Class: I KGO Product Code: February 29, 2000 Dated: March 8, 2000 Received:
Dear Mr. Awang:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಕ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation 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
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Page 2 - Mr. Awang
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.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on compriation 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 ene regaracion " (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
Timothy A. Ulatowski
Tin othy A. Ulatows Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) NUMBER (IF KNOWN):
K 993201
DEVICE NAME: Sterile Powder-Free Latex Surgical Gloves
INDICATIONS FOR USE:
A sterile power-free latex surgeon's glove is a disposable device intended for medical purpose that is worn by operating room personnel to protect a surgical wound from contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
SEB for Clin
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control,
Division of Dental, Devices Division of Demand Hospital Devices and General Hospital Books
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).