K Number
K093835
Device Name
BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN
Manufacturer
Date Cleared
2011-02-04

(416 days)

Product Code
Regulation Number
878.4040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BAM STANDARD. REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS are sterile, single use, blue SMS Surgical Gowns intended to protect surgical patients and operating room personnel from the transfer of micro-organisms, body fluids and particulate material. The BAM STANDARD and REINFORCED SURGICAL GOWNS meet Level 3 of AAM Liguid Barrier Classifications and the BAM ULTRA REINFORCED GOWNS meet Level 4 of the AAMI Liquid Barrier Classifications in their critical zones. The base material of the gowns is the same for the three categories. The sizing is the same except the BAM ULTRA REINFORCED GOWNS are longer. The only other difference is the chest and sleeve reinforcement panels added. BAM Reinforced blue SMS Surgical Gowns have a one layer SMS fabric added to the chest and sleeves. BAM Ultra Reinforced Blue SMS Surgical Gowns have a PET + PE film reinforcement added to the chest and sleeves. These gowns have been EtO sterilized. BAM STANDARD, REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS are also sold as bulk non-sterile, single use items, to repackager/ relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
Device Description
BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns are full-length, nonwoven SMS polypropylene gowns. They are constructed with hook and loop neck closures and tie waist closures. The BAM Standard Surgical Gown has an extra layer of SMS fabric reinforcement in the sleeves and BAM Reinforced Surgical Gown has an extra layer of fabric in critical areas. The Ultra Reinforced Gown has an extra layer of film Reinforced fabric in the critical areas for higher Barrier protection. BAM Standard and Reinforced Surgical Gowns meet the requirements for the Association for the Advancement of Medical Instrumentation (AAMI) Level 3 Requirements for liquid barrier performance. The BAM Ultra Reinforced Surgical Gown fully meets the requirements of AAMI Level 4 Liquid barrier requirements for Critical areas. The BAM Standard, Reinforced and Ultra-Reinforced and their predicates are provided sterile or nonsterile and for single use.
More Information

Not Found

Not Found

No
The 510(k) summary describes surgical gowns and their barrier properties, with no mention of AI or ML technology.

No.
The device (surgical gowns) is intended to protect patients and personnel from the transfer of microorganisms, body fluids, and particulate material, acting as a barrier rather than providing any therapeutic effect.

No

Explanation: The device is a surgical gown, which is a protective barrier for medical personnel and patients, not a device used to diagnose medical conditions.

No

The device described is a surgical gown, which is a physical, textile-based medical device, not a software-only device.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the gowns are "intended to protect surgical patients and operating room personnel from the transfer of micro-organisms, body fluids and particulate material." This is a protective barrier function, not a diagnostic one.
  • Device Description: The description focuses on the physical construction, materials, and barrier performance levels (AAMI levels). There is no mention of analyzing samples from the human body to provide diagnostic information.
  • Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting specific analytes or markers
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions.

The device is a surgical gown, which is a type of personal protective equipment used in a healthcare setting.

N/A

Intended Use / Indications for Use

BAM STANDARD. REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS are sterile, single use, blue SMS Surgical Gowns intended to protect surgical patients and operating room personnel from the transfer of micro-organisms, body fluids and particulate material. The BAM STANDARD and REINFORCED SURGICAL GOWNS meet Level 3 of AAM Liguid Barrier Classifications and the BAM ULTRA REINFORCED GOWNS meet Level 4 of the AAMI Liquid Barrier Classifications in their critical zones. The base material of the gowns is the same for the three categories. The sizing is the same except the BAM ULTRA REINFORCED GOWNS are longer. The only other difference is the chest and sleeve reinforcement panels added. BAM Reinforced blue SMS Surgical Gowns have a one layer SMS fabric added to the chest and sleeves. BAM Ultra Reinforced Blue SMS Surgical Gowns have a PET + PE film reinforcement added to the chest and sleeves. These gowns have been EtO sterilized.

BAM STANDARD, REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS are also sold as bulk non-sterile, single use items, to repackager/ relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

Product codes (comma separated list FDA assigned to the subject device)

FYA

Device Description

BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns are full-length, nonwoven SMS polypropylene gowns. They are constructed with hook and loop neck closures and tie waist closures. The BAM Standard Surgical Gown has an extra layer of SMS fabric reinforcement in the sleeves and BAM Reinforced Surgical Gown has an extra layer of fabric in critical areas. The Ultra Reinforced Gown has an extra layer of film Reinforced fabric in the critical areas for higher Barrier protection. BAM Standard and Reinforced Surgical Gowns meet the requirements for the Association for the Advancement of Medical Instrumentation (AAMI) Level 3 Requirements for liquid barrier performance. The BAM Ultra Reinforced Surgical Gown fully meets the requirements of AAMI Level 4 Liquid barrier requirements for Critical areas. The BAM Standard, Reinforced and Ultra-Reinforced and their predicates are provided sterile or nonsterile and for single use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Operating room personnel during surgical procedures; healthcare facilities.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

BAM Standard and Reinforced Surgical Gowns have been tested in compliance with the requirements of AAMI Level 3 liquid barrier performance requirements of ANSI/AAMI PB70 :2003 " Liquid barrier performances and classification of protective apparel and drapes intended for use in healthcare facilities." The critical zones of BAM Ultra Reinforced Surgical Gowns have been tested in compliance with Level 4 liquid barrier performance requirements of ANSI/AAMI PB70:2003.

In addition BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns have been tested and meet the requirements for Class 1, "normal flammability" in accordance with 16 CFR Part 1610. These devices also meet The requirements for biocompatibility per ISO 10993-10

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Kimberly Clark Ultra Surgical Gown, Kimberly Clark Ultra Film Reinforced Surgical Gown

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

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K093835
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510(k) Summary

| Regulatory Affairs Contact | Ms. Mary Mejaes
BAM Corporation Ltd.
Unit 1706 Tower 2, Grand Central Plaza
No. 138 Shatin Rural Committee Rd.
Shatin, Hong Kong | | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Telephone: | 852-2314-1300 | | |
| Fax: | 852-2314-1317 | | |
| Email: | mary@bam-corp.com | | |
| Date Summary Prepared: | June 23, 2010 | | |
| Common Name: | BAM Standard Surgical Gown
BAM Reinforced Surgical Gown
BAM Ultra-Reinforced Surgical Gown | | |
| Classification Name: | Surgical Gowns
Class 2, 21 CFR 878: 4040, Product FYA | | |
| Predicate Device: | Kimberly Clark Ultra Surgical Gown
Kimberly Clark Ultra Film Reinforced
Surgical Gown | | |
| Device Description: | BAM Standard, Reinforced and Ultra Reinforced
Surgical Gowns are full-length, nonwoven SMS
polypropylene gowns. They are constructed with
hook and loop neck closures and tie waist
closures. The BAM Standard Surgical Gown has
an extra layer of SMS fabric reinforcement in the
sleeves and BAM Reinforced Surgical Gown has
an extra layer of fabric in critical areas. The
Ultra Reinforced Gown has an extra layer of film
Reinforced fabric in the critical areas for higher
Barrier protection. BAM Standard and
Reinforced Surgical Gowns meet the requirements
for the Association for the Advancement of
Medical Instrumentation (AAMI) Level 3 | | |

1

Requirements for liquid barrier performance. The BAM Ultra Reinforced Surgical Gown fully meets the requirements of AAMI Level 4 Liquid barrier requirements for Critical areas. The BAM Standard, Reinforced and Ultra-Reinforced and their predicates are provided sterile or nonsterile and for single use. BAM Surgical Gowns are devices that are Intended Use intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. BAM Standard, Reinforced and Ultra Reinforced Substantial Equivalence Surgical Gowns are substantially equivalent to the predicate, Kimberly Clark Ultra Surgical Gown and Kimberly Clark Ultra Reinforced Surgical Gowns in intended use, design, materials and biocompatibility attributes. BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns and their predicates are provided for single use and either Sterile or Non- sterile.

ProductAspectComparison
BAM Standard, Reinforced and Ultra Reinforced Surgical GownsBasic Intended UseSame as Kimberly Clark Ultra and Ultra Reinforced Surgical Gowns
BAM Standard, Reinforced and Ultra Reinforced Surgical GownsMaterial UsedSMS, Same as Kimberly Clark Ultra and Ultra Reinforced Surgical Gowns
BAM Standard, Reinforced and Ultra Reinforced Surgical GownsSterilitySame as Kimberly Clark Ultra and Ultra Reinforced Surgical Gowns both sterile by EtO or non-sterile
BAM Standard, Reinforced, Ultra Reinforced Surgical GownsTestingSame barrier testing and AAMI barrier classification levels as Kimberly Clark Ultra and Ultra Reinforced Surgical Gowns.

2

Summary of Testing

BAM Standard and Reinforced Surgical Gowns have been tested in compliance with the requirements of AAMI Level 3 liquid barrier performance requirements of ANSI/AAMI PB70 :2003 " Liquid barrier performances and classification of protective apparel and drapes intended for use in healthcare facilities." The critical zones of BAM Ultra Reinforced Surgical Gowns have been tested in compliance with Level 4 liquid barrier performance requirements of ANSI/AAMI PB70:2003.

In addition BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns have been tested and meet the requirements for Class 1, "normal flammability" in accordance with 16 CFR Part 1610. These devices also meet The requirements for biocompatibility per ISO 10993-10

Conclusion

The above statements are true representations of the Standard, Reinforced and Ultra Reinforced Surgical Gowns BAM Corporation Ltd. intends to market that believes the subject devices are substantially equivalent to the predicate devices. All data and information in the premarket notification are truthful and accurate and no material fact has been omitted.

49 Page

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling the image of an eagle. The eagle is stylized with three lines representing the department's commitment to health, services, and human needs. The seal is a symbol of the HHS's mission to protect the health of all Americans and provide essential human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Mary Mejaes Director of Official Cerrespondent BAM Corporation Limited Unit 1706, Tower 2, Grand Central Plaza, No. 138 Shatin Rural Committee Road Shatin N.T. Hong Kong

FEB - 4 201

Re: K093835

Trade/Device Name: BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: January 3, 2011 Received: January 5, 2011

Dear Ms. Mejaes:

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.

4

Page 2-Ms. Mejacs

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/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 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

5

Indications for Use

510(k) Number: K093835

Device Name: BAM STANDARD, REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS

Indications For Use:

BAM STANDARD. REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS are sterile, single use, blue SMS Surgical Gowns intended to protect surgical patients and operating room personnel from the transfer of micro-organisms, body fluids and particulate material. The BAM STANDARD and REINFORCED SURGICAL GOWNS meet Level 3 of AAM Liguid Barrier Classifications and the BAM ULTRA REINFORCED GOWNS meet Level 4 of the AAMI Liquid Barrier Classifications in their critical zones. The base material of the gowns is the same for the three categories. The sizing is the same except the BAM ULTRA REINFORCED GOWNS are longer. The only other difference is the chest and sleeve reinforcement panels added. BAM Reinforced blue SMS Surgical Gowns have a one layer SMS fabric added to the chest and sleeves. BAM Ultra Reinforced Blue SMS Surgical Gowns have a PET + PE film reinforcement added to the chest and sleeves. These gowns have been EtO sterilized.

BAM STANDARD, REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS are also sold as bulk non-sterile, single use items, to repackager/ relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

See Page 2 for a Product List

| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) | X |
|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|---|
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED) | | | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
| Division Sign-Off
Office of Anesthesiology, General Hospital
Infection Control, Dental Devices | | | |
| 510(k) | | | |
| | Elite F. Clavins-Well (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices | | |
| 510(k) Number: | K093835 Page 29 | | |

6

No.Model No.NameSizeCategory
1L: 1990
XL:1991
XXL: 1992OR SMS Gown, Standard with Fabric
Reinforcement Sleeves
(BAM Sterile Standard blue SMS Surgical
Gowns)Large (L), X-Large (XL),
XX-Large (XXL)Standard
2.L: 1990U
XL:1991U
XXL: 1992UOR SMS Gown, Standard with Fabric
Reinforcement Sleeves
(BAM Non-sterile Standard blue SMS
Surgical Gowns)Large (L), X-Large (XL),
XX-Large (XXL)Standard
3.L:2000
XL:2001
XXL:2002OR SMS Gown, with Fabric Reinforcement
Chest and Sleeves
(BAM Sterile Reinforced blue SMS
Surgical Gowns)Large (L), X-Large (XL),
XX-Large (XXL)SMS Fabric
Reinforced
4.L:2000U
XL:2001U
XXL:2002UOR SMS Gown, with Fabric Reinforcement
Chest and Sleeves
(BAM Non-sterile Reinforced blue SMS
Surgical Gowns)Large (L), X-Large (XL),
XX-Large (XXL)SMS Fabric
Reinforced
5.L: 2010
XL:2011
XXL: 2012OR SMS Gown, with Film Reinforcement
Chest and Sleeves
(BAM Sterile Ultra Reinforced blue SMS
Surgical Gowns)Large (L), X-Large (XL),
XX-Large (XXL)PET+ PE Film
Reinforced
6.L: 2010U
XL:2011U
XXL: 2012UOR SMS Gown, with Film Reinforcement
Chest and Sleeves
(BAM Non-sterile Ultra Reinforced blue
SMS Surgical Gowns)Large (L), X-Large (XL),
XX-Large (XXL)PET+PE Film
Reinforced

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