(211 days)
The Biogel® OrthoPro® Indicator® Underglove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The proposed device, the Biogel® OrthoPro® Indicator® Underglove is manufactured of natural rubber latex. The Biogel® OrthoPro® Indicator® Underglove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years.
The glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® Indicator Underglove to provide the user with these additional features:
- . Slightly Curved Former with Independent/Displaced thumb
- Improved Fit, Feel and Comfort (compared to the current Biogel" Orthopaedic Surgical Glove)
The Molnlycke Healthcare Biogel® OrthoPro® Indicator® Underglove is a disposable natural rubber latex glove intended for use as a barrier against infectious material and contaminants in surgical settings.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria Met? |
|---|---|---|
| Dimensions | Meets ASTM D3577 | Yes |
| Physical Properties | Meets ASTM D3577 | Yes |
| Freedom from Holes | Meets ASTM D3577 | Yes |
| Biocompatibility | Meets ISO 10993-1 | Yes |
| LAL Test Results | Meets ASTM D7102 | Yes |
| Protein Extractables | Meets ASTM D5712 (with a limit of ≤50μg/g total water extractable protein) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (Dimensions, Physical Properties, etc.) nor the provenance of the data (country of origin, retrospective/prospective). It only states that "Performance Data" are summarized, indicating that tests were performed to demonstrate compliance with the listed ASTM and ISO standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The ground truth for this device is based on established scientific and engineering standards (ASTM and ISO), not on expert clinical consensus.
4. Adjudication Method
This information is not applicable as the evaluation is based on objective measurements against defined standards, not on subjective expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. The device is a physical barrier (glove), and its performance is evaluated against material and physical property standards, not through clinical comparative effectiveness in a diagnostic or therapeutic context that would involve human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. The device is a physical product (glove), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used
The ground truth used for evaluating the device is based on established scientific and engineering standards (e.g., ASTM D3577 for dimensions, physical properties, and freedom from holes; ISO 10993-1 for biocompatibility; ASTM D7102 for LAL; and ASTM D5712 for protein extractables). These standards define objective criteria and test methods that the device must meet.
8. Sample Size for the Training Set
This information is not applicable. The device is a manufactured product, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a manufactured glove. The "ground truth" for compliance testing is inherent in the internationally recognized and accepted ASTM and ISO standards themselves.
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Image /page/0/Picture/0 description: The image shows the logo for Molnlycke Healthcare. The logo consists of a cluster of four circles on the left side of the image. To the right of the circles is the text "MOLNLYCKE HEALTHCARE" in a sans-serif font.
1101163
NOV-2-3-2010-
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Biogel® OrthoPro® Indicator® Underglove
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
Date Prepared:
April 8, 2010
Norcross, GA 30092 Registration number:
Owner/Operator Number:
Applicant:
Official Correspondent:
Trade/Proprietary Name:
Common Name:
Device Class:
Product Code:
Classification Name:
Regulation Number:
Predicate Device Name(s):
Angela L. Bunn, RAC Director, Regulatory Affairs of the Americas Tel: 678-250-7930 Fax: 678-250-7981 e-mail: angela.bunn@molnlycke.com
3004763499
9067000
Biogel® OrthoPro® Indicator® Underglove
Mölnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500.
Surgeon's Glove
Surgeon`s Glove
Class I
21 CFR 878.4460
KGO
Biogel® Indicator Underglove (K071565 and K980942) Biogel® Orthopedic Surgical Glove (K071465)
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Description of Device:
424 HEARE
The proposed device, the Biogel® OrthoPro® Indicator® Underglove is manufactured of natural rubber latex. The Biogel® OrthoPro® Indicator® Underglove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years.
The glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® Indicator Underglove to provide the user with these additional features:
- . Slightly Curved Former with Independent/Displaced thumb
- Improved Fit, Feel and Comfort (compared to the current Biogel" Orthopaedic Surgical Glove)
Intended Use/Indication for Use:
The Biogel® OrthoPro® Indicator® Underglove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Technological Characteristics:
The Biogel® OrthoPro® Indicator® Underglove is substantially equivalent to the Biogel® Indicator" Underglove (K071565 and K980942) and Biogel" Orthopedic Surgical Glove (K071465).
All of the assessed devices have similar indications for use, materials, product design, labeling claims and method of operation.
The difference in the proposed device, Biogel® OrthoPro® Indicator® Underglove is the thickness and a slight change to the former.
The Biogel® OrthoPro® Indicator® Underglove characteristics are summarized below as compared to ASTM requirements.
Characteristic Dimensions Physical Properties Freedom from Holes Biocompatibility LAL Test Results Protein Extractables
Standard Meets ASTM D3577 Meets ASTM D3577 Meets ASTM D3577 Meets ISO 10993-1 ASTM D7102 ASTM D5712
Performance Data:
The performance data are summarized above.
.
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-Clinical Testing:
No clinical data was required.
Conclusion:
Based on the performance testing, it can be concluded that the Biogel® OrthoPro® Indicator Underglove is equivalent to the Biogel® Indicator* Underglove (K071565 and K980942) and Biogel® Orthopedic Surgical Glove (K071465) predicates with respect to intended use, materials, design, and technological characteristics.
Market Barbara Baran Baran Baran The couple the more of the don't Martin Subscription of
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Angela L. Bunn Director , Regulatory Affairs Molnycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
NOV 2 3 2010
Re: K101163
Trade/Device Name: Biogel® OrthoPro® Indicator® Underglove with <50ug/g total water extractable protein statement Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: November 11, 2010 Received: November 12, 2010
Dear Ms. Bunn:
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.
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Page 2- Ms. Bunn
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 (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.
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 notification" (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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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
NOV 2 3 2010
510(k) Number (if known): K101163
Biogel® OrthoPro® Indicator® Underglove with ≤50μg/g total water Device Name: extractable protein statement
Indications For Use:
The Biogel® OrthoPro® Indicator® Underglove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Prescription Use -------
AND/OR
Over-The-Counter Use X
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Eldith F. Clarence-Will
Division Sign-Off) 'ivision of Anesthesiology, General Hospital tection Control, Dental Devices
10(k) Number: K101163
Page 1 of
Mölnlycke Health Care US, LLC, Tel 678-250-7900 5550 Peachtree Parkway, Suite 500 Fax 678-2507984 Norcross, GA 30092 www.molnlycke.com
§ 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).