(70 days)
BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves
This is a 510(k) premarket notification for "BarrierPlus® Platinum Powder-Free Synthetic Polychloroprene Surgical Gloves." This type of submission relies on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance. Therefore, the traditional elements of a study proving a device meets acceptance criteria as typically found in clinical trials or AI/software validation studies are largely absent in this document.
However, I can extract information related to what would be considered "performance" in the context of a surgical glove and the regulatory process.
Based on the provided document, here's what can be inferred and what information is missing:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for a surgical glove, the "performance" is primarily assessed against established standards for barrier integrity and biocompatibility, typically demonstrated through bench testing rather than clinical "performance" metrics in the way one might evaluate a diagnostic algorithm. The document doesn't explicitly state the acceptance criteria values or the reported device performance in a table, but surgical gloves are subject to specific ASTM or ISO standards for testing.
Inferred Performance Criteria (based on general surgical glove requirements):
| Performance Criterion (Inferred) | Acceptance Criteria (Typical for Surgical Gloves) | Reported Device Performance (Not explicitly stated in this document, but implied to meet predicate standards) |
|---|---|---|
| Freedom from Holes | AQL (Acceptable Quality Limit) of 1.5 or 2.5 | Implied to meet AQL for surgical gloves |
| Tensile Strength | Meets or exceeds specified standards (e.g., ASTM D412) | Implied to meet predicate device's performance |
| Elongation at Break | Meets or exceeds specified standards (e.g., ASTM D412) | Implied to meet predicate device's performance |
| Puncture Resistance | Meets or exceeds specified standards | Implied to meet predicate device's performance |
| Biocompatibility (Dermal Sensitivity) | Non-irritating, non-sensitizing | Implied to be non-irritating/non-sensitizing |
| Powder-Free Status | Meets powder residue limits (if applicable) | Stated as "Powder-Free" |
| Sterility (if applicable) | Sterility Assurance Level (SAL) | Not explicitly mentioned but surgical gloves are typically sterile |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this document. For physical properties, sample sizes would be defined by the relevant ASTM or ISO standards (e.g., for AQL testing).
- Data Provenance: Not specified. Testing would typically be conducted by the manufacturer or a third-party lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the context of this 510(k) summary. This type of information is relevant for clinical studies involving expert interpretation (e.g., reading medical images). For a surgical glove, "ground truth" is established by adherence to physical and chemical standards, not expert adjudication.
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers in a clinical setting. This is a bench-tested device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a physical medical device (surgical glove), not an AI/software device or a diagnostic tool that involves human readers interpreting data.
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:
- For the performance characteristics of a surgical glove, the "ground truth" is defined by established international and national standards (e.g., ASTM International, ISO standards) for physical properties (tensile strength, elongation, freedom from holes) and biocompatibility testing (e.g., ISO 10993 series). The device's performance is compared against these normative standards, often by comparison to a legally marketed predicate device that already meets these standards.
8. The sample size for the training set:
- Not Applicable. This device is not an AI/machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. This device is not an AI/machine learning algorithm.
Summary of what the document does provide:
- Device Name: BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves
- Intended Use: To be worn by operating room personnel to protect a surgical wound from contamination.
- Regulatory Classification: Class I, Product Code KGO
- Predicate Device: The substantial equivalence determination is based on a comparison to a legally marketed predicate device (not named in this snippet, but would be detailed in the full 510(k) submission). The assumption is that the new device performs as safely and effectively as the predicate by meeting relevant recognized standards.
- Regulatory Pathway: 510(k) premarket notification, indicating no new safety or effectiveness concerns compared to a predicate.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2006
Mr. Victor J. Ragucci Chairman & CEO BarrierMed, Glove Company® 155 Technology Park Lake Mary, Florida 32746
Re: K061038
Trade/Device Name: BarrierPlus® Platinum Powder-Free Synthetic Polychloroprene Surgical Gloves Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: June 8, 2006 Received: June 13, 2006
Dear Mr. Ragucci:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Mr. Ragucci
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Claire Liu, Ph.D.
Chiu Lin. Ph.D. 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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3.0 Indications for Use Statement:
INDICATIONS FOR USE
| Applicant: | BarrierMed Glove Co.® |
|---|---|
| ------------ | ----------------------- |
| 510(k) Number (if known) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | :------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|---|
Device Name: BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves
Indications For Use:
BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shala A. Mynher KS 6/23/06
nacthesincev.
Number: Kol 1038
- For a new submission, do NOT fill in the 510(k) number.
CONFIDENTIAL
BarrierMed Glove Co.
Page 6 of 15
§ 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).